IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed

IRB Responsibilities related to investigator qualifications, site adequacy, and whether an IND/IDE is needed - guidance

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Elemental Impurities in Drug Products Guidance for Industry

Pharmaceutical Quality/CMC

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Field Alert Report Submission: Questions and Answers Guidance for Industry

Pharmaceutical Quality/Manufacturing Standards (CGMP).
and Pharmaceutical Quality/CMC.

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Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use

Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use

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Ignatius P. Godoy, M.D. - 561662 - 10/01/2018

Bioresearch Monitoring Program/IRB  


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2018 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

This is the main page for the 2018 Meeting Materials, Vaccines and Related Biological Products Advisory Committee.

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FDA puts company on notice for marketing unapproved stem cell products for treating serious conditions

FDA puts company on notice for marketing unapproved stem cell products for treating serious conditions

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Vaccines

CBER regulates vaccine products. Vaccine information includes a listing of vaccines approved for marketing, questions about vaccines, vaccine safety and availability, and vaccine-related guidance documents, notices, and rules.

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Blood & Blood Products

CBER regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components. FDA has strengthened the safeguards that protect patients from unsuitable blood and blood products and has increased its oversight of the blood industry.

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Development & Approval Process (CBER)

Key resources and information related to CBER development & approval process.

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Allergenics

Lists three types of allergenic products licensed for use: allergen extracts, allergen patch tests, and antigen skin tests. Allergen extracts are used for the diagnosis and/or treatment of allergic diseases such as allergic rhinitis ("hay fever"), allergic sinusitis, allergic conjunctivitis, bee venom allergy and food allergy. Allergen patch tests are diagnostic tests applied to the surface of the skin. Antigen skin tests are diagnostic tests injected into the skin to aid in the diagnosis of infection with certain pathogens.

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Weather News Why are we seeing so many tornadoes? Jennifer Ketchmark 10:34 AM, May 30 - WCPO

1. Weather News Why are we seeing so many tornadoes? Jennifer Ketchmark 10:34 AM, May 30  WCPO
2. Tornado warnings are meant to save lives. Why do some people roll their eyes?  USA TODAY
3. Tornado, severe weather outbreak most 'prolonged stretch' in 8 years -- and here's why  Fox News
4. Here's why the US has seen tornadoes, floods and extreme heat in the past few weeks  CNN
5. Tornado season in overdrive: What's behind the extreme weather hitting Oklahoma, Midwest areas like Kansas City, Ohio, Indiana  CBS News
6. View full coverage on Google News

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BIMO/Team Biologics/Internet Surveillance/Other

This is the main page for the CBER BIMO/Team Biologics/Internet Surveillance/Other.

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Roster of the Blood Products Advisory Committee

This is the Roster of the Blood Products Advisory Committee (BPAC).

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Exceptions and Alternative Procedures Approved Under 21 CFR 640.120

Title 21 Code of Federal Regulations 640.120(a) - The Director, Center for Biologics Evaluation and Research, may approve an exception or alternative procedures to any requirement in subchapter F (Biologics) of Chapter I (Parts 600 - 680) of title 21 of the Code of Federal Regulations regarding bloo

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13 straight days of tornadoes shatter US twister record, leave heartland storm-weary - AccuWeather.com

1. 13 straight days of tornadoes shatter US twister record, leave heartland storm-weary  AccuWeather.com
2. Trump calls Ohio governor to offer support after tornadoes | TheHill  The Hill
3. Tornado, severe weather outbreak most 'prolonged stretch' in 8 years -- and here's why  Fox News
4. Tornadoes stretch into Pennsylvania  10TV
5. Cities are not tornado-free zones, as Dayton just showed. Map your safety plan in advance: Walter Topp (Opinion)  cleveland.com
6. View full coverage on Google News

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Trump calls Ohio governor to offer support after tornadoes | TheHill - The Hill

1. Trump calls Ohio governor to offer support after tornadoes | TheHill  The Hill
2. Tornado, severe weather outbreak most 'prolonged stretch' in 8 years -- and here's why  Fox News
3. 'Seek shelter immediately!': Texas braces as tornadoes continue assault on nation  USA TODAY
4. NWS confirms 8 tornadoes touched down in Ohio Monday night  WJW FOX 8 News Cleveland
5. Cities are not tornado-free zones, as Dayton just showed. Map your safety plan in advance: Walter Topp (Opinion)  cleveland.com
6. View full coverage on Google News

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Using a Centralized IRB Review Process in Multicenter Clinical Trials

Guidance for Industry: Using a Centralized IRB Review Process in Multicenter Clinical Trials

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Tornado that obliterated Linwood, Kansas, was mile-wide EF4 twister with top winds of 170 mph - AccuWeather.com

1. Tornado that obliterated Linwood, Kansas, was mile-wide EF4 twister with top winds of 170 mph  AccuWeather.com
2. Tornado Rips Through Kansas City Suburbs As Vicious Storms Move East  HuffPost
3. Tornado, severe weather outbreak most 'prolonged stretch' in 8 years -- and here's why  Fox News
4. Kansas declares tornado emergency  ABC News
5. KCI Airport remains closed due to unsafe conditions from area storm debris  KQ2.com
6. View full coverage on Google News

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Adverse Event Reporting to IRBs

Adverse Event Reporting to IRBs - Guidance

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Cellular & Gene Therapy Products

CBER provides oversight of clinical studies, proactive scientific and regulatory advice to medical researchers and manufacturers of cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy.

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Resources Related to Regenerative Medicine Therapies

Information on FDA’s Framework for the Regulation of Regenerative Medicine Products


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Standards Development for Regenerative Medicine Therapies

Section 3036 of the 21st Century Cures Act refers to the development of standards for regenerative medicine therapies, including products designated regenerative medicine advanced therapies.

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Food

Timely articles and multimedia content about food and food-safety.

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FDA Researchers Advance Science for Vaccines to Prevent Mumps and Whooping Cough

Reported cases of mumps and pertussis have risen in the US in recent years even though many people are vaccinated. As part of the FDA commitment to protect the public health, FDA scientists are working to learn why more cases are occurring.

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May 29, 2019 at 09:27AM Une décennie pour renforcer les synergies entre agriculture familiale et agroécologie

Les agriculteurs familiaux sont au cœur des transitions liées à la sécurité alimentaire, à la biodiversité ou au changement climatique. Selon la définition de la FAO, l’agriculture familiale constitue 90 % des exploitations dans le monde, produit environ les deux tiers de l’alimentation mondiale et couvre plus de la moitié des surfaces agricoles. Mesurant ce rôle majeur, et après le succès d’une année internationale en 2014, les Nations Unies dédient désormais aux agricultures familiales une décennie. Celle-ci est officiellement lancée le 29 mai 2019 à la FAO à Rome. Le Cirad est présent.

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Kansas declares tornado emergency, at least 11 injured - ABC News

1. Kansas declares tornado emergency, at least 11 injured  ABC News
2. At least 1 killed after large, destructive overnight tornado strikes Dayton, nearby Ohio communities  AccuWeather.com
3. Ohio Task Force 1 assisting in search in rescues efforts after Dayton-area tornado  10TV
4. 1 dead, 130 injured as twisters rip through Ohio and Indiana  WLWT Cincinnati
5. 'Tornado Outbreak' Devastates Ohio Communities With Winds Up To 140 MPH  NPR
6. View full coverage on Google News

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Large, dangerous tornado touches down in Kansas City; severe weather moves east into Missouri - USA TODAY

1. Large, dangerous tornado touches down in Kansas City; severe weather moves east into Missouri  USA TODAY
2. Tornado outbreak across the US: Live updates  CNN
3. Tornado emergency declared in Kansas City as dangerous storm moves in  CBS News
4. Tornado reported touching down in Kansas City vicinity  The Washington Post
5. Large and dangerous tornado touches down in Kansas City  ABC News
6. View full coverage on Google News

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Informed Consent

Informed Consent Information Sheet - Draft Guidance

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A Guide to Informed Consent

Everything you need to know about Informed Consent

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AFLURIA QUADRIVALENT

For active immunization of persons ages 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.

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Celina man killed in tornado outbreak - WDTN.com

1. Celina man killed in tornado outbreak  WDTN.com
2. Ohio tornado hurls vehicle at home killing elderly man  BBC News
3. Destructive tornadoes slam Ohio, killing one  The Washington Post
4. 1 dead, 7 hurt as storms rip through Celina  WANE
5. One dead, seven injured during Monday night storm system in Celina  wpta21.com
6. View full coverage on Google News

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Office of Compliance and Biologics Quality (OCBQ)

Office of Compliance and Biologics Quality (OCBQ)

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Foreign Regulators – Information and Training Resources

FDA’s Office of International Programs (OIP) coordinates and facilitates the Agency’s Capacity Building Program which includes technical cooperation and assistance efforts. CBER partners with OIP in many of those activities, but also leads the effort in regulatory capacity building for regulated products specific to CBER.

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Innovation and Regulatory Science

Innovation and Regulatory Science

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Clinical Review - Fluarix

•For active immunization of persons 3 years of age and older for the prevention of disease caused by influenza virus subtypes A and type B contained in the vaccine.

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May 24, 2019 at 01:43PM Montpellier Declaration: “Make Our Planet Treed Again”

Over a thousand experts from a hundred countries meeting in Montpellier, France, for the 4th World Congress on Agroforestry called for a ‘transformative change’ to tackle the disastrous impacts on our planet of the global food system that were documented in the recent IPBES report on biodiversity. Agroforestry, they agreed, was crucial to that effort. The event was organized by CIRAD and INRA, in partnership with World Agroforestry (ICRAF), Agropolis International and Montpellier University of Excellence.

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PROVENGE (sipuleucel-T)

For the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

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CDC: number of measles cases in US grows to 940 - KCRG

1. CDC: number of measles cases in US grows to 940  KCRG
2. The Viral Threat: Measles and Misinformation | Fault Lines  Al Jazeera English
3. U.S. measles outbreak grows with 60 new measles cases across 26 states  Reuters
4. US measles outbreak now worst since 1994 after 60 new cases reported  The Guardian
5. New measles cases reported in outbreak that touches 26 states | TheHill  The Hill
6. View full coverage on Google News

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Aldi recalls flour after E. coli outbreak sickens 17 people in 8 states - Fox Business

Aldi recalls flour after E. coli outbreak sickens 17 people in 8 states  Fox Business

Aldi has recalled all five-pound bags of Baker's Corner All Purpose Flour Thursday because of the potential presence of E. coli, which was discovered during a ...

View full coverage on Google News

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ALDI issues recall for flour brand amid E. coli concerns - WTAE Pittsburgh

1. ALDI issues recall for flour brand amid E. coli concerns  WTAE Pittsburgh
2. Flour sold at Aldi recalled after 17 people in 8 states get sick  CNN
3. E. coli outbreak linked to Aldi flour after 17 ill; flour recalled in 11 states  USA TODAY
4. CDC: Aldi flour in Massachusetts linked to E. coli outbreak  MassLive.com
5. ADM Milling recalling Baker’s Corner All Purpose Flour 5lb bags packaged for ALDI  FOX61 Hartford
6. View full coverage on Google News

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ALDI issues recall for flour brand amid E. coli concerns - WTAE Pittsburgh

1. ALDI issues recall for flour brand amid E. coli concerns  WTAE Pittsburgh
2. Flour sold at ALDI recalled after 17 people in 8 states get sick  CNN
3. E. coli outbreak linked to Aldi flour after 17 ill; flour recalled in 11 states  USA TODAY
4. Flour Recall at Aldi Stores in Delaware - WBOC-TV 16, Delmarvas News Leader, FOX 21 -  WBOC TV 16
5. CDC: Aldi flour in Massachusetts linked to E. coli outbreak  MassLive.com
6. View full coverage on Google News

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Flour sold at ALDI recalled after 17 people in 8 states get sick - CNN

Flour sold at ALDI recalled after 17 people in 8 states get sick  CNN

The CDC and FDA are investigating the multistate outbreak of E. coli infections linked to flour.

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Flour sold at ALDI recalled after 17 people in 8 states get sick - CNN

Flour sold at ALDI recalled after 17 people in 8 states get sick  CNN

The CDC and FDA are investigating the multistate outbreak of E. coli infections linked to flour.

View full coverage on Google News

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Flour sold at ALDI recalled after 17 people in 8 states get sick - CNN

Flour sold at ALDI recalled after 17 people in 8 states get sick  CNN

The CDC and FDA are investigating the multistate outbreak of E. coli infections linked to flour.

View full coverage on Google News

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E. coli outbreak linked to Aldi flour, which is being recalled in 11 states - USA TODAY

1. E. coli outbreak linked to Aldi flour, which is being recalled in 11 states  USA TODAY
2. ALDI issues recall for flour brand amid E. coli concerns  WTAE Pittsburgh
3. ALDI issues recall for Bakers Corner flour over E. coli concerns  WJW FOX 8 News Cleveland
4. Flour Recall at Aldi Stores in Delaware - WBOC-TV 16, Delmarvas News Leader, FOX 21 -  WBOC TV 16
5. Aldi recall: Flour recalled over possible E. coli contamination  CBS News
6. View full coverage on Google News

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Licensed Biological Products with Supporting Documents

Licensed biological products with supporting documents is arranged alphabetically by the proper name of the product(s). Information is provided for original product approvals, new indications, and the current package insert.

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Approved Cellular and Gene Therapy Products

Listing of licensed and approved products from the Office of Tissues and Advanced Therapies (OTAT).

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Workshops, Meetings & Conferences (Biologics)

Information on CBER sponsored or co-sponsored meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties.

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Humanitarian Device Exemption (HDE) Program

This draft guidance document to provide clarity to industry and FDA staff about the current review practices for the Humanitarian Device Exemption (HDE) Program.

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Cleared 510(k) Submissions with Supporting Documents - 2019

List of Cleared 510(k) Submissions with Supporting Documents for 2019

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May 24, 2019 at 01:43PM Déclaration de Montpellier : « Reverdir notre planète avec l’agroforesterie ! »

Plus d’un millier d’experts de cent pays ont appelé à Montpellier, à l’issue du 4e congrès mondial d’agroforesterie, à un changement profond du système alimentaire mondial pour en limiter les impacts négatifs sur notre planète*. L'agroforesterie, ont-ils convenu, a un rôle essentiel à jouer dans cet effort. Ce congrès était organisé, pour la première fois en Europe, par le Cirad et l'Inra, en partenariat avec World Agroforestry, Agropolis International et Montpellier Université d’Excellence.

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May 23, 2019 at 05:32PM Perspective 51. Geospatial information for African agriculture: a key investment for agricultural policies

Geospatial information and its derived products, designed to contribute to public agricultural policy making, are not widely used in Africa. The infrastructure, training and skills are lacking, and research and development activities are dispersed and inadequate. More importantly, needs are not formalised and technological resources, driven by the industrialised countries, are ill-adapted to the characteristics of agricultural systems in Africa. Moreover, companies, institutions and projects require a stable environment to ensure operational services, relevant products and useful information. These co-constructed services emerge within long-term partnerships between researchers, consultancies and end users. Research thus offers new opportunities for using satellite imagery to document and explain agricultural transformation processes. Finally, lasting interdisciplinary skills networks are needed to facilitate methodological and thematic exchanges.

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May 24, 2019 at 10:20AM Diversity of Family Farming Around the World

The diversity of local and national family farming situations, studied with a single methodological frame gives sense to the family-based farming choice for the future. An original adaptation and a challenging test of the widely used sustainable rural livelihood framework. A wide participation of authors from academic and development bodies.

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May 24, 2019 at 10:02AM Colloque de Cérisy - Sciences, techniques et agricultures

Avec la participation et le soutien du Cirad, ainsi que de l'Ifris, de l'Inra, de l'AFD et du ministère français de l'Agriculture et de l'Alimentation.

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May 24, 2019 at 07:16AM Ressources, inégalités et développement des territoires ruraux en Amérique Latine, dans la Caraïbe et en Europe

Colloque organisé dans le cadre de la semaine de l'Amérique latine et des Caraïbes, par l'Institut des Amériques (IdA), la Fondation EU-LAC et l’Agence française du développement (AFD), avec le Cirad et le CNRS pour la coordination scientifique.

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Blood Products Advisory Committee March 20 - 21, 2019 Meeting Announcement - 03/20/2019 - 03/21/2019

This is the CBER Blood Products Advisory Committee March 20 - 21, 2019 Meeting Announcement.

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Food

Timely articles and multimedia content about food and food-safety.

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FDA Consumer Updates About Food

Timely articles and multimedia content about food and food-safety.

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Direct Recall Classification Program

CBER's Direct Recall Classification (DRC) program provides establishments the opportunity to electronically report recall related information directly to CBER.

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Confused by Date Labels on Packaged Foods?

Consumer uncertainty about the meaning of the dates that appear on the labels of packaged foods is believed to contribute to about 20 percent of food waste in the home. Here are some ways to reduce food loss and waste, without risking illness from consuming spoiled food.

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May 23, 2019 at 05:32PM Perspective N° 51. Geospatial information for African agriculture: a key investment for agricultural policies

Geospatial information and its derived products, designed to contribute to public agricultural policy making, are not widely used in Africa. The infrastructure, training and skills are lacking, and research and development activities are dispersed and inadequate. More importantly, needs are not formalised and technological resources, driven by the industrialised countries, are ill-adapted to the characteristics of agricultural systems in Africa. Moreover, companies, institutions and projects require a stable environment to ensure operational services, relevant products and useful information. These co-constructed services emerge within long-term partnerships between researchers, consultancies and end users. Research thus offers new opportunities for using satellite imagery to document and explain agricultural transformation processes. Finally, lasting interdisciplinary skills networks are needed to facilitate methodological and thematic exchanges.

via CIRAD - Actualités / News http://bit.ly/2wbKdor

May 23, 2019 at 05:32PM L’information géospatiale au service de l’agriculture africaine, un investissement essentiel pour les politiques agricoles

Les informations géospatiales et leurs produits dérivés, conçus pour contribuer à la définition des politiques publiques agricoles, sont peu utilisés en Afrique. Les infrastructures, la formation et les compétences manquent ; les activités de recherche et développement sont dispersées et insuffisantes. Mais, surtout, les besoins restent mal formalisés et l’offre technologique, impulsée par les pays industrialisés, est peu adaptée aux caractéristiques des agricultures africaines. Par ailleurs, pour que des services opérationnels produisent de l’information pertinente et utile, un environnement stable doit être garanti aux entreprises, aux institutions et aux projets. Ces services co-construits naissent dans le cadre d’un partenariat pérenne entre les chercheurs, les opérateurs chargés des études et les utilisateurs finaux. La recherche ouvre alors d’autres voies d’exploitation des images satellitaires pour documenter et expliciter les processus de transformation de l’agriculture. Enfin, des réseaux de compétences interdisciplinaires structurés sur le temps long sont nécessaires pour favoriser les échanges méthodologiques et thématiques.

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InterSol Solution/Platelet Additive Solution 3

InterSol solution is an isotonic solution designed to replace a proportion of the plasma used in the storage of AMICUSâ„¢-derived leukoreduced apheresis platelets. Posted: 12/10/2009

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Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use

Guidance for Industry and Food and Drug Administration Staff for Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use, CBER, Biologics, December 2017

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Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories

To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities

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Suspected tornado kills 3 people as severe weather slams Central US again - Axios

Suspected tornado kills 3 people as severe weather slams Central US again  Axios

Missouri Department of Public Safety said 3 people died in a storm in the state's southwest state and the National Weather Service confirmed a "violent tornado" ...

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Border crisis must be fixed by Congress, top official says after migrant teen dies in US custody - Fox News

1. Border crisis must be fixed by Congress, top official says after migrant teen dies in US custody  Fox News
2. Border Facility Temporarily Suspends Migrant Intake After 32 Identified With Flu  NPR
3. US border: Calls for inquiry after teen dies in detention  BBC News
4. McAllen, Texas CPB facility: Facility stops taking in migrants after teen's death and widespread flu-like illness  CBS News
5. 'Thank God We're OK.' Migrants Tell Of Conditions In A Texas CBP Holding Facility  NPR
6. View full coverage on Google News

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Tornado in Jefferson City, Mo., may have caused ‘catastrophic damage’: reports - Fox News

1. Tornado in Jefferson City, Mo., may have caused ‘catastrophic damage’: reports  Fox News
2. LIVE: Deadly tornado outbreak strikes central US  AccuWeather.com
3. 'Violent tornado' takes aim at Jefferson City after 3 killed in southwest Missouri  NBCNews.com
4. LIVE BLOG: Jefferson City sees widespread damage from observed tornado  ABC17News.com
5. Suspected tornado kills 3 people as severe weather slams Central US again  Axios
6. View full coverage on Google News

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Border crisis must be fixed by Congress, top official says after migrant teen dies in US custody - Fox News

1. Border crisis must be fixed by Congress, top official says after migrant teen dies in US custody  Fox News
2. Border Facility Temporarily Suspends Migrant Intake After 32 Identified With Flu  NPR
3. US border: Calls for inquiry after teen dies in detention  BBC News
4. McAllen, Texas CPB facility: Facility stops taking in migrants after teen's death and widespread flu-like illness  CBS News
5. Feds stop processing migrants at Texas border center after 32 test positive for flu  ABC News
6. View full coverage on Google News

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CAUGHT ON CAMERA: Storm spotter captures tornado near Carl Junction, Mo. Wednesday - KY3

1. CAUGHT ON CAMERA: Storm spotter captures tornado near Carl Junction, Mo. Wednesday  KY3
2. Tornado in Jefferson City, Mo., may have caused ‘catastrophic damage’: reports  Fox News
3. Suspected tornado kills 3 people as severe weather slams Central US again  Axios
4. Remembering the 2011 Joplin, Missouri Tornado | Survivor Shares His Story  ABC10
5. 3 fatalities confirmed in Golden City area after tornado  KoamNewsNow.com
6. View full coverage on Google News

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The Latest: Arkansas River town ordered evacuated - Fox News

1. The Latest: Arkansas River town ordered evacuated  Fox News
2. LIVE: Deadly tornado outbreak strikes central US  AccuWeather.com
3. Residents Ordered to Evacuate Oklahoma Town as Waters Rise; Several Tornadoes Reported  The Weather Channel
4. Oklahoma town urges evacuation due to rising river  KSWO
5. Wichita, Kansas News, Weather, Sports - Oklahoma Governor surprised by amount of flooding  KAKE
6. View full coverage on Google News

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FDA Researchers Advance Science for Vaccines to Prevent Mumps and Whooping Cough

Reported cases of mumps and pertussis have risen in the US in recent years even though many people are vaccinated. As part of the FDA commitment to protect the public health, FDA scientists are working to learn why more cases are occurring.

via Consumer Updates RSS Feed http://bit.ly/2HKN5xU

Los investigadores de la FDA logran avances científicos en las vacunas para prevenir las paperas y la tosferina

El número de casos de paperas y tosferina en los Estados Unidos ha aumentado en los últimos años, a pesar de que muchas personas son vacunadas. Como parte de su compromiso de proteger la salud pública, los científicos de la FDA se esfuerzan por saber por qué se están presentando más casos y cómo las vacunas —que ya son seguras y eficaces— pueden mejorarse aún más. He aquí lo que debe saber.

via Consumer Updates RSS Feed http://bit.ly/2VWSoEu

FDA Researchers Advance Science for Vaccines to Prevent Mumps and Whooping Cough

Reported cases of mumps and pertussis have risen in the US in recent years even though many people are vaccinated. As part of the FDA commitment to protect the public health, FDA scientists are working to learn why more cases are occurring.

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/2HKN5xU

Los investigadores de la FDA logran avances científicos en las vacunas para prevenir las paperas y la tosferina

El número de casos de paperas y tosferina en los Estados Unidos ha aumentado en los últimos años, a pesar de que muchas personas son vacunadas. Como parte de su compromiso de proteger la salud pública, los científicos de la FDA se esfuerzan por saber por qué se están presentando más casos y cómo las vacunas —que ya son seguras y eficaces— pueden mejorarse aún más. He aquí lo que debe saber.

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Predicting Stem Cell Activity to Ensure Safe and Effective Therapies

Predicting Stem Cell Activity to Ensure Safe and Effective Therapies

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Roster of the Vaccines and Related Biological Products Advisory Committee

This is the Roster of the Vaccines and Related Biological Products Advisory Committee

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Bovine Spongiform Encephalopathy (BSE) Questions and Answers

Bovine Spongiform Encephalopathy (BSE) Questions and Answers

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Texas Migrant Detention Center Shuts Down Over Flu Outbreak - The Daily Beast

1. Texas Migrant Detention Center Shuts Down Over Flu Outbreak  The Daily Beast
2. Brother of Guatemalan teen who died in U.S. Border Patrol custody speaks out  CBS News
3. No Wall Can Fill Holes in the Law  The Wall Street Journal
4. Dems call for investigation after migrant teen dies in US custody  ABC News
5. New details on Guatemalan migrant teen who died in U.S. custody  CBS News
6. View full coverage on Google News

via Top stories - Google News http://bit.ly/2weKOWp

May 20, 2019 at 02:59PM Artificial intelligence to model complex agroforestry systems

An innovative project has just been launched at CIRAD to model cocoa agroforestry systems using artificial intelligence. This ambitious programme, called Deep2DPE, will explore three research fronts: the mathematics of modelling, artificial intelligence (neural networks and machine learning) and agronomy to optimise agroforestry systems by modelling them. This third objective should, for example, enhance understanding of how competition for light between species affects cocoa production.

via CIRAD - Actualités / News http://bit.ly/2VSjGvA

OraQuick Rapid HIV-1/2 Antibody Test

Allow for an added labeling claim for the detection of antibodies to HIV-1 and HIV-2 in plasma specimens and the detection of HIV-1 antibodies in oral fluid specimen

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Animal Rule Information

Links to information about the Animal Rule, which may be used to grant marketing approval of certain products when human challenge studies would not be ethical or feasible

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Vaccines and Related Biological Products Advisory Committee March 22, 2019 Meeting Announcement - 03/22/2019 - 03/22/2019

This is the CBER Vaccines and Related Biological Products Advisory Committee March 22, 2019 Meeting Announcement.

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Framework for the Regulation of Regenerative Medicine Products

Comprehensive policy framework for the regulation of regenerative medicine products.

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Vaccines Licensed for Use in the United States

The product name and trade name of vaccines licensed for use in the United States.

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May 18, 2019 at 05:21PM Food security: innovation for better water resource management in North Africa

The MASSIRE project takes a participatory approach to select innovations with high potential for water management and to assess the conditions for their adoption in North Africa. The project will strengthen the capacities of young rural people working in family farming, through training and networking. Launched in early May at the Institut Agronomique et Vétérinaire Hassan II (Hassan II Institute of Agronomy and Veterinary Medicine) in Rabat (Morocco), this four-year long project, coordinated by CIRAD, will be implemented with its partners in North Africa, thanks to a 2 million euro grant from the International Fund for Agricultural Development (IFAD)*.

via CIRAD - Actualités / News http://bit.ly/30CNIlw

May 21, 2019 at 03:40PM Agroforesterie et services écosystémiques en zone tropicale

Un e-book gratuit qui rassemble l’ensemble des connaissances sur le fonctionnement et la dynamique des systèmes agroforestiers en région tropicale.

via CIRAD - Actualités / News http://bit.ly/2YI1IbV

Biologics PREA Reviews and Labeling Changes

PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under section 505 of the Act and biological drugs licensed under section 351 of the Public Health Service Act.

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May 18, 2019 at 11:38AM Agroforestry clusters, a model to complement fair trade

Agroforestry cropping systems, highly productive hybrid coffee plants and a local value chain organized by interconnected stakeholders: these are the three pillars of the agroforestry cluster (AFS-Cluster*) concept developed by CIRAD. A pilot cluster created in 2016 produced the Nespresso “Nicaragua” pod. This organizational innovation of an agricultural sector seems to complement ecological and social certification systems and fair trade. The model will be presented at the World Congress on Agroforestry, from 20 to 22 May in Montpellier.

via CIRAD - Actualités / News http://bit.ly/2WVrRUh

A Tattoo for You? Seven Key Questions to Consider

As tattoos have become more popular, the number of people suffering from infections and other bad reactions has also increased.

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Think Before You Ink: Are Tattoos Safe?

Are tattoos safe? Not always. More people are getting tattoos, and some have developed infections from contaminated inks, or had bad reactions to the inks themselves.

via Consumer Updates RSS Feed http://bit.ly/2QiZVY8

Manufacturing Site Change Supplements: Content and Submission

This guidance explains what constitutes a manufacturing site change and when you should submit a PMA supplement for a site change; what documentation you should submit in a site change supplement; and the general factors FDA intends to consider when determining whether conduct an inspection.

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Manufacturing Site Change Supplements: Content and Submission

FDA's current thinking regarding manufacturing site changes and PMA supplements, documentation to submit, and general factors considered.

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Strong, long-tracking tornadoes likely as yet another severe weather outbreak looms for central US - AccuWeather.com

1. Strong, long-tracking tornadoes likely as yet another severe weather outbreak looms for central US  AccuWeather.com
2. Dangerous Tornado Outbreak, Major Flash Flooding Expected Today in Texas, Oklahoma  The Weather Channel
3. 2 million people are at 'high' risk for catastrophic tornadoes in parts of Oklahoma and Texas  CNN
4. Oklahoma County Emergency Management urges two steps for storm safety  KOKH FOX25
5. Tornado Outbreak for the Southern Plains Monday  WeatherNation
6. View full coverage on Google News

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Dangerous, violent tornado outbreak predicted for Monday - USA TODAY

1. Dangerous, violent tornado outbreak predicted for Monday  USA TODAY
2. Dangerous Tornado Outbreak, Major Flash Flooding Expected Today in Texas, Oklahoma  The Weather Channel
3. Strong to Severe Storms Possible Monday Afternoon  Boston News, Weather, Sports | WHDH 7News
4. Oklahoma County Emergency Management urges two steps for storm safety  KOKH FOX25
5. Tornadoes roar through nation: 'All the windows exploded, it was just chaos'  USA TODAY
6. View full coverage on Google News

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Dangerous, violent tornado outbreak predicted for Monday - USA TODAY

1. Dangerous, violent tornado outbreak predicted for Monday  USA TODAY
2. Dangerous Tornado Outbreak, Major Flash Flooding Expected Today in Texas, Oklahoma  The Weather Channel
3. Tornadoes destroy homes across Southern Plains ahead of 'significant severe weather event'  Fox News
4. Oklahoma County Emergency Management urges two steps for storm safety  KOKH FOX25
5. Tornadoes roar through nation: 'All the windows exploded, it was just chaos'  USA TODAY
6. View full coverage on Google News

via Top stories - Google News http://bit.ly/2WhifpP

May 20, 2019 at 02:59PM L’intelligence artificielle pour modéliser les systèmes agroforestiers complexes

Un projet novateur vient de démarrer au Cirad pour modéliser les systèmes agroforestiers cacaoyers grâce à l’intelligence artificielle. Ce programme ambitieux, appelé Deep2DPE, va explorer trois fronts de recherche : en mathématiques de la modélisation, en intelligence artificielle (réseaux de neurones et apprentissage automatique) et en agronomie pour optimiser les systèmes agroforestiers grâce à leur modélisation. Ce troisième objectif devrait permettre par exemple de comprendre comment la compétition pour la lumière entre les espèces affecte la production de cacao.

via CIRAD - Actualités / News http://bit.ly/2Qcss1d

Storms hit Friday night from southwest Nebraska into the central part of the state - Omaha World-Herald

1. Storms hit Friday night from southwest Nebraska into the central part of the state  Omaha World-Herald
2. Life-threatening tornado outbreak, flash flooding possible Monday in Southern Plains  ABC News
3. Dozens of tornadoes reported as central US braces for rain, wind and hail  CNN
4. Dozens of tornadoes have struck the Plains since Friday, with a serious outbreak feared on Monday  The Washington Post
5. Strong storms move through Tulsa County, northeast Oklahoma Saturday  Tulsa World
6. View full coverage on Google News

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May 18, 2019 at 05:21PM Sécurité alimentaire : innover pour mieux gérer la ressource en eau au Maghreb

Le projet Massire vise à sélectionner à travers une approche participative des innovations à fort potentiel en matière de gestion de l’eau et à évaluer leurs conditions d’adoption en Afrique du Nord. Il renforcera les capacités des jeunes ruraux issus de l’agriculture familiale, par de la formation et de la mise en réseau. Lancé début mai à l’Institut Agronomique et Vétérinaire Hassan II à Rabat (Maroc), ce projet de 4 ans, coordonné par le Cirad, sera mis en œuvre avec ses partenaires au Maghreb, grâce à un don de 2 millions du Fond International pour le Développement Agricole (FIDA)*.

via CIRAD - Actualités / News http://bit.ly/2WedAF7

Dozens of tornadoes reported in Nebraska, Kansas as severe weather slams central US - AccuWeather.com

1. Dozens of tornadoes reported in Nebraska, Kansas as severe weather slams central US  AccuWeather.com
2. Dozens of tornadoes reported as powerful storm system threatens millions of Americans  CBS News
3. Central US braces for rain, wind and hail as dozens of tornadoes reported  CNN
4. Strong storms possible Saturday in Kansas City  KMBC Kansas City
5. Severe weather outbreak could affect millions this weekend across the central US  FOX 5 San Diego
6. View full coverage on Google News

via Top stories - Google News http://bit.ly/2W8TtZ8

May 18, 2019 at 11:38AM Les clusters agroforestiers, un modèle complémentaire au commerce équitable

Cultures en agroforesterie, caféiers hybrides hautement productifs et chaine de valeur locale orchestrée par des parties prenantes interconnectées. Tels sont les trois piliers du concept de cluster agroforestier (AFS-Cluster*) développé au Cirad. Un cluster pilote constitué en 2016 a donné naissance à la capsule Nespresso « Nicaragua ». Cette innovation organisationnelle d’une filière agricole semble compléter des certifications écologiques et sociales comme le commerce équitable. Le modèle sera présenté lors du congrès mondial d’agroforesterie qui se tient du 20 au 22 mai à Montpellier.

via CIRAD - Actualités / News http://bit.ly/2Q6L6Yk

A severe weather outbreak could affect millions this weekend across the central US - CNN

1. A severe weather outbreak could affect millions this weekend across the central US  CNN
2. Severe Weather Possible Over the Weekend  week.com
3. Tornadoes, hail and severe winds could hit central U.S.  CBS Evening News
4. First Alert Weather Day: Strong thunderstorms expected in East Texas by late Saturday morning  KLTV
5. Active weather pattern returns  WIBW
6. View full coverage on Google News

via Top stories - Google News https://cnn.it/2LPn6uA

Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans

Source Animal Product Preclinical, Clinical Issues, Xenotransplantation Products in Humans, Guidance for Industry, CBER, Biologics

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PHS Guideline on Infectious Disease Issues in Xenotransplantation

This is the PHS Guideline on Infectious Disease Issues in Xenotransplantation, CBER, Biologics

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Public Health Issues Posed by the Use of Non-Human Primate Xenografts in Humans

This is the Guidance For Industry: Public Health Issues Posed by the Use of Non-Human Primate Xenografts in Humans, CBER, Biologics

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Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts

This guidance document represents FDA’s current thinking on testing limits in stability protocols for standardized grass pollen extracts. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. Allergenic, CBER, Biologics

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Questions about Tissues

Information about tissues, questions and answers, donor screening and testing, donor eligibility

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FDA Voices on Consumer Safety and Enforcement

FDA Voices on Consumer Safety and Enforcement

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Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies

Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies Draft Guidance for Industry, CBER, Biologics

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/2LTJkvk

Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies

Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; final; C. difficile infection, Fecal microbiota, CBER, Biologics

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Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies

Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies, guideline, combination, vaccine, disease, guidance document, CBER, Biologics

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/2EjocbM

Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product

Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product, CBER, Biologics

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How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1)

Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1)., guidance, VAERS, vaccine, adverse event, reporting, CBER, Biologics

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Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines

Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines, CBER, Biologics

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Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol

The release limits for standardized dust mite and grass allergen vaccines are based on the performance characteristics of the competition Enzyme-Linked Immunosorbent Assay (ELISA) for the determination of the relative potency (RP) of these products.

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FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information

Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information, CBER, Biologics

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Vaccine and Related Biological Product Guidances

This page contains a listing of vaccine and related biological product guidances

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Development of Preventive HIV Vaccines for Use in Pediatric Populations

Guidance for Industry: Development of Preventive HIV Vaccines for Use in Pediatric Populations, CBER, Biologics

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Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications

This is Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications, CBER, Biologics

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Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines

This is Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines

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Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines

Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines, CBER, Biologics

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Considerations for Plasmid DNA Vaccines for Infectious Disease Indications

Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications, final, vaccines

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Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials

Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, CBER, Biiologics

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/2JpZH0q

Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications

Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications, CBER, Biologics

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/2JsNDvE

General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases

Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases. condition endemic, vaccines, CBER, Biologics

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/2JJrfgG

Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review

Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review, Guidance for Industry, Technical Specifications Document, OVRR, CBER, Biologics, Application Submissions Guidance, Vaccine and Related Biological Product Guidance, Study Data Standards Resources Guidance

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Providing Submissions in Electronic Format — Postmarketing Safety Reports for Vaccines

Providing Submissions in Electronic Format-Postmarketing Safety Reports for Vaccines - Guidance for Industry, CBER, Biologics

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Consumer Updates

Get timely, reliable, health and safety information about food, drugs, medical devices, vaccines, pet food, pet medicine and more.

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SHINGRIX

This is the main page for the CBER SHINGRIX.

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FDA Voices on Medical Products

FDA Voices on Medical Products

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Screening and Testing of Donors of Human Tissue Intended for Transplantation

This is the Guidance for Industry: Screening and Testing of Donors of Human Tissue Intended for Transplantation, CBER, Biologcs

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Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens

Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens, CBER, Biologics, Development Stage, Donor Screening Tests, Cadaveric Blood Specimens

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Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), CBER, Biologics, Development Stage, labeling, donor screening

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Validation of Procedures for Processing of Human Tissues Intended for Transplantation

Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for Transplantation, CBER, Biologics, Processing of Human Tissues, Transplantation

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Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements

This is the Guidance for Industry: Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements., CBER, Biologics, Development Stage final

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Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide

Guidance for Industry: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide, ,CBER, biologics, guidance, industry, tissue, cell, cellular, compliance

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Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests

Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests, CBER, biologics, guidance, industry, cell, tissue, cellular, HCT/P, donor, disease, testing

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Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container

Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container, CBER, Biologics, Development Stage, Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container, CBER, Biologics

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Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis)

Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis, CBER, Biologics

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Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271

Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271 Guidance for Industry, cber, biologics

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Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).

Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), CBER, Biologics

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Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates

Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components, CBER, Biologics, Tissue

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Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Guidance document describing the Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), CBER, Biologics

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Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products

Nucleic Acid Tests, NAT, Tissue, Donor Eligibility, Hepatitis B Virus, Human Cells, Tissues, and Cellular and Tissue-Based Products, CBER, Biologics

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Emergency Use Authorization

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies

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Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products

Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Product Guidance for Industry, CBER, Biologics, Tissue

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Antimicrobial Resistance Information from FDA

Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR.

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Section 8400: Marketing Applications

This is the SOPP Section 8400: Marketing Applications main page.

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Section 8100: Communication

This is the CBER SOPP Section 8100: Communication main page.

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Blood Grouping Reagent, Anti-k (Monoclonal) (IgG) (For Further Manufacturing Use)

Blood Grouping Reagent, Anti-k (Monoclonal) (IgG) (For Further Manufacturing Use)

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Guidance for Human Somatic Cell Therapy and Gene Therapy

Guidance for Industry Guidance for Human Somatic Cell Therapy and Gene Therapy, CBER, Biologics

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Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products

Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry, cell, tissue, cellular, hct/p, donor, guidance, donor eligibility, donor testing, blood, hiv, hbv, hcv, cjd, tse

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Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors

Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors, CBER, Biologics

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Gene Therapy Clinical Trials - Observing Subjects for Delayed Adverse Events

Guidance for Industry: Gene Therapy Clinical Trials - Observing Subjects for Delayed Adverse Events, CBER, Biologics

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Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs)

Guidance for Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs), CBER, Biologics

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Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)

Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs), CBER, Biologics

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/2W9KbvU

Considerations for Allogeneic Pancreatic Islet Cell Products

Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products, CBER, Biologics

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Cellular Therapy for Cardiac Disease

Guidance for Industry: Cellular Therapy for Cardiac Disease, CBER, biologics

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Clinical Considerations for Therapeutic Cancer Vaccines

Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines, CBER, Biologics

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FDALabel: Full-Text Search of Drug Labeling

FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 100,000 labeling documents for FDA-approved drug products, including human and animal prescription and over-the-counter drugs, biological products, and medical devices.

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Potency Tests for Cellular and Gene Therapy Products

Final Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products, CBER, Biologics

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Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage

Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage, CBER, Biologics

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IND Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System

IND Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System, CBER, Biologics


via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/2W33Ldd

BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System

Guidance for Industry: BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorder, BLA, Biologics License Applications, Allogeneic, Placental, Umbilical Cord Blood, Hematopoietic, Immunologic

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/2LKsi2C

Preclinical Assessment of Investigational Cellular and Gene Therapy Products

Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products, CBER, Biologics


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Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products

This is the Final Guidance for Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry - PDF Version

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Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products

Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry, Biologics

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Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products

Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Guidance for Industry, CBER, Biologics

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Long Term Follow-up After Administration of Human Gene Therapy Products

Long Term Follow-up After Administration of Human Gene Therapy Products, Draft Guidance, CBER, Biologics

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Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)

Draft Guidance,Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs), CBER, Biologics

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/2W92aCy

CBER Vaccine ICSR – Proposed Updates

In support of the “Postmarketing Safety Reporting for Combination Products” rule, FDA is proposing to update VAERS Electronic Reporting Resource

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/2LK8w7h

Expedited Programs for Regenerative Medicine Therapies for Serious Conditions

Guidance for Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, CBER, Biologics

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5 Things to Know About Triclosan

Triclosan is an ingredient added to many consumer products to help reduce or prevent bacterial contamination. Are there benefits?

via Consumer Updates RSS Feed http://bit.ly/2YvggeZ

Antibacterial Soap? You Can Skip It, Use Plain Soap and Water

Think antibacterial soaps reduce your risk of getting an infection? Not necessarily, the FDA says. There is no data demonstrating that over-the-counter antibacterial soaps are better at preventing illness than washing with plain soap and water.

via Consumer Updates RSS Feed http://bit.ly/30oiNcB

5 Things to Know About Triclosan

Triclosan is an ingredient added to many consumer products to help reduce or prevent bacterial contamination. Are there benefits?

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/2YvggeZ

Real-World Evidence

Real-world data (RWD) and real-world evidence (RWE) played an increasing role in health care decisions. The 21st Century Cures Act, passed in 2016, placed additional focus on the use of these types of data to support regulatory decision making.

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ACAM2000

ACAM2000 is a product approval indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.

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Vaccines

CBER regulates vaccine products. Vaccine information includes a listing of vaccines approved for marketing, questions about vaccines, vaccine safety and availability, and vaccine-related guidance documents, notices, and rules.

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/2VoSTBT

December 16, 2014 Approval Letter – INTERCEPT Blood System for Plasma

Intended to be used for the ex vivo preparation of pathogen-reduced, whole blood derived or apheresis plasma in order to reduce the risk of transfusion-transmitted infection (TTI).

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December 18, 2014 Approval Letter - INTERCEPT Blood System for Platelets

Intended to be used for ex vivo preparation of apheresis platelet components in order to reduce the risk of transfusion-transmitted infection (TTI) including sepsis, and to potentially reduce the risk of transfusion-associated graft versus host disease (TA-GVHD).

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/2Q4Gq5m

May 15, 2019 at 11:51AM Le Cirad conclut un accord avec la SATT AxLR pour mieux valoriser ses recherches

Le Cirad a conclu le 13 mai un accord de partenariat avec la SATT AxLR pour renforcer les moyens de transfert et de valorisation des travaux de ses 32 unités de recherche.

via CIRAD - Actualités / News http://bit.ly/2W6t65Q

May 15, 2019 at 11:51AM Le Cirad conclut un accord avec la SATT AxLR pour mieux valoriser ses recherches

Le Cirad a conclu le 13 mai un accord de partenariat avec la SATT AxLR pour renforcer les moyens de transfert et de valorisation des travaux de ses 32 unités de recherche.

via CIRAD - Actualités / News http://bit.ly/2HlSe0j

May 15, 2019 at 07:44PM Global mapping of tree microbial symbioses reveals their key role in climate regulation

A global map of tree microbial symbioses, produced by the Global Forest Biodiversity Initiative (GFBI), is front-page news in the 16 May issue of Nature . CIRAD, which is on the GFBI Steering Committee, helped coordinate the gathering and analysis of data on tropical forests. The researchers involved demonstrated that if carbon emissions continue at current rates, 10% des of tree ectomycorrhizal fungi will have disappeared by 2070. In a snowball effect, this would trigger even higher carbon emissions.

via CIRAD - Actualités / News http://bit.ly/30q3P5S

September 05, 2019 at 12:50PM Who's in Clinical Trials?

FDA is making demographic information from clinical trials, such as the inclusion of women and minority groups, more easily available and transparent to consumers.

via Consumer Updates RSS Feed http://bit.ly/30otU5h

August 05, 2019 at 12:45PM Animal & Veterinary

Consumer articles from FDA about animal health and veterinary medicine.

via Consumer Updates RSS Feed http://bit.ly/2VnZHzT

July 05, 2019 at 10:30AM Tips to Stay Safe in the Sun: From Sunscreen to Sunglasses

The U.S. Food and Drug Administration is continuing to evaluate sunscreen products to help protect consumers from sunburn. Because certain sunscreens can help prevent skin cancer caused by the sun when used as directed with other sun protection measures, it's important to know how to use them properly. Also learn about other ways to protect yourself from sun damage.

via Consumer Updates RSS Feed http://bit.ly/30mJQW0

Labeling of Red Blood Cell Units with Historical Antigen Typing Results

Labeling of Red Blood Cell Units with Historical Antigen Typing Results guidance for industry, CBER, Biologics, Blood

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Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances

Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances, CBER, Biologics

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Guideline for the Uniform Labeling of Blood and Blood Components

Guideline for the Uniform Labeling of Blood and Blood Components, CBER, Biologics

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Draft Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to the Human Immunodeficiency Virus Type 1

This is the Draft Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to the Human Immunodeficiency Virus Type 1.

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Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers ("High Risk" Donors)

Guideline for collection of blood or blood products from donors with positive tests for infectious disease markers high risk donors, CBER, biologics, blood

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/30qFXiT

Draft Points to Consider in the Design and Implementation of Field Trials for Blood Grouping Reagents and Anti-Human Globulin

Draft Points to Consider in the Design and Implementation of Field Trials for Blood Grouping Reagents and Anti-Human Globulin , CBER, biologics

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Draft Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin

Draft Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin, cber, biologics, blood

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/30o6HAv

Guideline for Quality Assurance in Blood Establishments

This is the Guideline for Quality Assurance in Blood Establishments, biologics, blood, establishments, quality assurance, QA

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Draft Recommended Methods for Blood Grouping Reagents Evaluation

Draft Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin, CBER, Biologics

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/30pIolM

Changes to an Approved Application: Biological Products

Changes to an Approved Application: Biological Products, CBER, Biologics

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Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products

2000 Date Change for Computer Systems and Software Applications, CBER, biologics, guidance, industry, blood, computer, software

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Donor Screening for Antibodies to HTLV-II

Guidance for Industry: Donor Screening for Antibodies to HTLV-II, blood, CBER, biologics

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Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing

Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing, blood, CBER, biologics

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For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products

Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products, blood, CBER, Biologics

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/2VpwCUt

Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product

Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product, blood, CBER, biologics

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/30mPlUy

Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use

Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use, Blood, CBER, Biologics

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/2VwT8Lu

In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2

In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2, Blood, CBER, Biologics

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/30pxCvu

Consumers (Biologics)

Resources for consumers on biological products.

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Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001

This is the Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001.

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/30lWHYl

Use of Sterile Connecting Devices in Blood Bank Practices

Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices, CBER, biologics, guidance, industry, blood, bank, sterile, connecting device

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/2VnhM0N

May 15, 2019 at 07:44PM Une cartographie mondiale des symbioses microbiennes des arbres révèle leur rôle clé dans la régulation du climat

Une cartographie mondiale des symbioses microbiennes des arbres vient d’être publiée en Une de Nature le 16 mai par l’Initiative pour la biodiversité des forêts mondiales (Global Forest Biodiversity Initiative - GFBI). Le Cirad, membre du comité de pilotage du GFBI, a contribué à la coordination de la collecte de données pour les forêts tropicales et à leur analyse. Les chercheurs ont montré que si les émissions de carbone se poursuivent d’ici 2070, 10 % des champignons ectomycorhiziens des arbres disparaîtront. Cela entraînerait, tel un effet boule de neige, des émissions encore plus importantes de carbone dans l’atmosphère.

via CIRAD - Actualités / News http://bit.ly/2Q6EYPK

May 15, 2019 at 11:51AM Le Cirad conclut un accord avec la SATT AxLR pour mieux valoriser ses recherches

Le Cirad a conclu le 13 mai un accord de partenariat avec la SATT AxLR pour renforcer les moyens de transfert et de valorisation des travaux de ses 32 unités de recherche.

via CIRAD - Actualités / News http://bit.ly/2HlSe0j

May 10, 2019 at 11:10AM The sixth mass extinction calls for stronger global governance of biodiversity and an economic paradigm shift

The report on the IPBES global assessment of biodiversity and ecosystem services is now out. One of the conclusions is that humans are responsible for a sixth mass extinction that could threaten their very existence. Profound economic, social, policy and technological change is vital.

via CIRAD - Actualités / News http://bit.ly/2WFfzPH

May 10, 2019 at 05:35PM Une agriculture durable, un sujet alimentaire: des arbres dans nos assiettes!

Une journée ouverte à tous les publics, organisée par l’Association Française d’Agroforesterie et la Fondation de France dans le cadre du Congrès Mondial d'Agroforesterie, en marge de la Comédie du livre de Montpellier. Avec la participation du Cirad.

via CIRAD - Agenda / Events http://bit.ly/2E1hmHL

May 10, 2019 at 11:10AM Face à la 6ème extinction de masse, renforcer la gouvernance mondiale de la biodiversité et changer de paradigme économique

Les conclusions du rapport sur l’évaluation mondiale de la biodiversité et des services écosystémiques, conduite par l’IBPES, sont tombées. L’Humanité est la cause d’une 6e extinction de masse, menaçant elle-même sa propre existence. De profonds changements, sur les plans économique, social, politique et technologique, sont nécessaires.

via CIRAD - Actualités / News http://bit.ly/308NUcd

May 06, 2019 at 05:00PM Sorgho, plante multi-usages : quels « nouveaux débouchés » prometteurs ?

Un atelier co-organisé par le Cirad.

via CIRAD - Agenda / Events http://bit.ly/2H7cRvM

Medicamentos

Información para el consumidor sobre la seguridad de los medicamentos y medicinas.

via Consumer Updates RSS Feed http://bit.ly/2UM6iUo

Taking Z-drugs for Insomnia? Know the Risks

Z-drugs (prescribed for insomnia) may help you sleep, but also carry serious risks. FDA is adding its most prominent warning, a Boxed Warning, to the label. Find out the benefits as well as risks of taking Z-drugs.

via Consumer Updates RSS Feed http://bit.ly/2IVRcdo

¿Toma medicamentos para el insomnio? Conozca los riesgos

Los medicamentos para dormir (prescritos para el insomnio) pueden ayudarlo a conciliar el sueño, pero también conllevan graves riesgos. La FDA está añadiendo su advertencia más visible -un recuadro de advertencia a la etiqueta. Descubra los beneficios y los riesgos de tomar medicamentos para dormir.

via Consumer Updates RSS Feed http://bit.ly/2Jc2F83

La mejor protección contra el sarampión es la vacunación

El sarampión no es una inofensiva enfermedad infantil. Es peligrosa y puede poner en peligro la vida. Nuestra medida de salud pública más eficaz contra el sarampión es la prevención mediante la vacuna contra el sarampión.

via Consumer Updates RSS Feed http://bit.ly/2ZKKdsZ

Fact or Fiction: What to Know About Smoking Cessation and Medications

Tobacco use is the leading preventable cause of death in the United States, resulting in more than 480,000 deaths annually. Almost 70 percent of current smokers report wanting to quit smoking, but quitting can be hard and often takes multiple attempts. Learn the facts.

via Consumer Updates RSS Feed http://bit.ly/2JbRmN8

The FDA Encourages New Treatments for Sickle Cell Disease

The U.S. Food and Drug Administration is collaborating with patients, academics, and the pharmaceutical industry to encourage the development of new treatments for sickle cell disease (SCD).

via Consumer Updates RSS Feed http://bit.ly/2ISMltq

Watch Out for False Promises About So-Called Alzheimer's Cures

Unfortunately, when faced with a serious health issue, even the most rational person can be led to believe implausible claims.

via Consumer Updates RSS Feed http://bit.ly/2JdaYAG

Vaccination Is the Best Protection Against Measles

Measles is not a harmless childhood disease. It's dangerous and can be life-threatening. Our most effective public health measure against measles is prevention with the measles vaccine.

via Consumer Updates RSS Feed http://bit.ly/2UMXayU

Nutrición

Información para el consumidor sobre la nutrición.

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Fraude en la Salud

Información para el consumidor sobre el fraude en la salud y cómo evitar ser estafado.

via Consumer Updates RSS Feed http://bit.ly/2UM6gvK

Watch Out for False Promises About So-Called Alzheimer’s Cures

These purported miracle cures are sold primarily on the Internet. They are often, though not always, falsely labeled as dietary supplements. Regardless of their form, these products fly in the face of true science. What these companies are selling is false hope.

via Consumer Updates RSS Feed http://bit.ly/2ZKKlst

Tenga cuidado con las falsas promesas de las supuestas curas para el Alzheimer

Tenga cuidado con las falsas promesas de las supuestas curas para el Alzheimer

via Consumer Updates RSS Feed http://bit.ly/2UMXkGw

Suplementos Dietéticos

Información para el consumidor sobre la seguridad de los suplementos dietéticos.

via Consumer Updates RSS Feed http://bit.ly/2ZMMUu0

Salud de la Mujer

Información para el consumidor sobre la salud de la mujer

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Salud Infantil

Información para el consumidor sobre la seguridad de medicamentos y alimentos para los niños.

via Consumer Updates RSS Feed http://bit.ly/2ZMMRhO

Dispositivos Médicos

Información para el consumidor sobre la seguridad y operación de los dispositivos médicos

via Consumer Updates RSS Feed http://bit.ly/2UMXcH2

Vacunas, Sangre y Productos Biológicos

Información para el consumidor sobre la seguridad de las vacunas, sangre y productos biológicos.

via Consumer Updates RSS Feed http://bit.ly/2ZKKfkB

May 02, 2019 at 11:19AM Conférence TEDx : des jeux pour résoudre des conflits

Claude Garcia, écologue au Cirad, veut « aider les populations à façonner leur avenir. » Comment ? En jouant. Le chercheur explique sa démarche originale avec passion et clarté dans une conférence TEDx, donnée à Zurich fin 2018. Ce TedTalk est le fruit de 6 années de partenariat entre le Cirad et l’École polytechnique fédérale de Zurich, au sein du groupe de recherche ForDev. Lui et ses collègues ont conçu des jeux issus des modèles de fonctionnement d’un territoire. Des jeux où les participants jouent leur propre rôle. Ils ont réussi à faire jouer d’anciens ministres, des représentants des gouvernements, des grandes entreprises et des bailleurs de fonds. L’année dernière, ces travaux innovants ont même permis d’obtenir un accord entre différents négociateurs sur la gestion des forêts primaires du Bassin du Congo. Un succès après deux ans de tentatives infructueuses par les méthodes classiques. Regardez.

via CIRAD - Actualités / News http://bit.ly/2DGgyYw