Friday, August 30, 2019

August 30, 2019 at 05:30PM Améliorer les services vétérinaires au travers de partenariats public-privé

L’Organisation mondiale de la santé animale (OIE) vient de publier un manuel répertoriant les lignes directrices pour des partenariats public-privé réussis dans le domaine vétérinaire. Un travail réalisé par l’OIE avec le Cirad et le soutien de la Fondation Bill & Melinda Gates.



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Abington Memorial Hospital, IRC - 576854 - 06/24/2019

Bioresearch Monitoring Program/IRB  


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Nine-year-old girl tests positive for Ebola in Uganda - CNN

  1. Nine-year-old girl tests positive for Ebola in Uganda  CNN
  2. World's 2nd-largest Ebola outbreak surpasses 3,000 cases  ABC News
  3. Ebola Outbreak in Congo Hits Milestone, and Death Toll Rises  The New York Times
  4. Ebola: Death Toll From DR Congo Outbreak Climbs Over 2,000  The Daily Beast
  5. DR Congo Ebola deaths top 2,000  BBC News
  6. View full coverage on Google News


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Thursday, August 29, 2019

Capcom may unveil a spiritual successor to 'Resident Evil Outbreak' - Engadget

  1. Capcom may unveil a spiritual successor to 'Resident Evil Outbreak'  Engadget
  2. Leaked Resident Evil Images Show Project Teased by Capcom for Tokyo Game Show - IGN  IGN
  3. New Resident Evil Project Will Debut Before TGS [Updated With New Images]  GameSpot
  4. Capcom teases new Resident Evil game, Project Resistance, for TGS 2019  Polygon
  5. Resident Evil-related reveal is coming in September  VentureBeat
  6. View full coverage on Google News


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Identification and Use of Biomarkers to Advance Development of Preventive Vaccines; Public Workshop - 09/16/2019 - 09/17/2019

The purpose of the public workshop is to exchange information with stakeholders from industry, academia, and government about the scientific, clinical, and regulatory challenges encountered in the identification, characterization, and qualification of biomarkers for use in the development of preventive vaccines for infectious diseases indications.

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Voluntary Drug Recall Extension - Kogenate FS Antihemophilic Factor (Recombinant)

Bayer is issuing a follow-up to the communication sent to customers on July 21, 2016 regarding a voluntary recall of two lots of hemophilia A drug Kogenate FS containing active ingredient manufactured before November 2015.

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Voluntary Drug Recall Extension - Helixate FS

CSL Behring is issuing a follow-up to the communication sent to customers on July 21, 2016 regarding a voluntary recall of two lots of hemophilia A drug Helixate FS containing active ingredient manufactured before November 2015.

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City of Milwaukee urges everyone who lives there to stop vaping immediately - CNN

  1. City of Milwaukee urges everyone who lives there to stop vaping immediately  CNN
  2. People are vaping THC. Lung injuries being reported nationwide. Why is the CDC staying quiet?  USA TODAY
  3. Milwaukee health officials urge residents to stop smoking e-cigarettes  CBS This Morning
  4. City of Milwaukee urges residents to stop vaping 'immediately'  ABC News
  5. Milwaukee issues health alert urging people to stop vaping amid outbreak of lung cases  USA TODAY
  6. View full coverage on Google News


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Section 8100: Communication

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

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Recalls (Biologics)

Biologic recalls are listed by year. Recalls are a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action.

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Vaccines and Related Biological Products Advisory Committee October 9, 2019 Meeting Announcement - 10/09/2019 - 10/09/2019

This is the CBER Vaccines and Related Biological Products Advisory Committee October 9, 2019 Meeting Announcement.

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2019 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

This is the main page for the CBER 2019 Meeting Materials, Vaccines and Related Biological Products Advisory Committee.

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Vaccines and Related Biological Products Advisory Committee November 8, 2019 Meeting Announcement - 11/08/2019 - 11/08/2019

This is the CBER Vaccines and Related Biological Products Advisory Committee November 8, 2019 Meeting Announcement.

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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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Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications

This guidance document describes the factors FDA considers when making benefit-risk determinations during premarket review for certain medical devices.

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Wednesday, August 28, 2019

Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus

We, FDA, are notifying you, blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, that we have determined Ebola virus to be a transfusion-transmitted infection (TTI) under Title 21 of the Code of Federal Regulations (CFR) 630.3

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Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products - Guidance for Industry and FDA

PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Comb.Prod

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Security Resources For Manufacturers of Biological Products

The physical security of biological products and the facilities in which they are manufactured and otherwise held is an important public health issue

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Section 8400: Marketing Applications

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

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FY 2018 Report from the Director

FY 2018 Report from the Director, Dr. Peter Marks

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August 28, 2019 at 02:58PM Congrès mondial de l'IUFRO

Le XVe congrès mondial de l'Union Internationale des Instituts de Recherche Forestière auquel participe le Cirad.



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Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for Industry

Clinical /Medical

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Tuesday, August 27, 2019

FDA Voices on Consumer Safety and Enforcement

FDA Voices on Consumer Safety and Enforcement

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FDA Voices on Policy

FDA Voices on Policy

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FDA Voices on Medical Products

FDA Voices on Medical Products

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Delivering Promising New Medicines Without Sacrificing Safety and Efficacy

All drugs approved under the Fast Track, Breakthrough Therapy, RMAT designation, and Priority Review expedited programs are held to the same approval standards as other FDA drug approvals.

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Developing a Toolkit to Assess Efficacy of Ebola Vaccines and Therapeutics

MCMi regulatory science project to research issues that are key to understanding and predicting if—and how—vaccines and therapeutics to prevent and treat Ebola will show efficacy

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Allergenic Products Advisory Committee September 13, 2019 Meeting Announcement - 09/13/2019 - 09/13/2019

This is the main page for the Allergenic Products Advisory Committee September 13, 2019 Meeting Announcement.

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Geenius HIV 1/2 Supplemental Assay

The Geenius HIV 1/2 Supplemental Assay is a single-use immunochromatographic assay for the confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2) in serum, or plasma samples from blood donors.

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Monday, August 26, 2019

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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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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November 30- December 1, 2017: Blood Products Advisory Committee Meeting Announcement - 11/30/2017 - 12/01/2017

This is the BPAC November 30- December 1, 2017: Blood Products Advisory Committee Meeting Announcement

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2017 Meeting Materials, Blood Products Advisory Committee

This is the lead page for 2017 Meeting Materials, Blood Products Advisory Committee

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Male Breast Cancer: Developing Drugs for Treatment

Draft guidance for industry: Male Breast Cancer: Developing Drugs for Treatment.

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Friday, August 23, 2019

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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VAXELIS

VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae (H. influenzae) type b. VAXELIS is approved for use as a 3 dose series in children 6 weeks through 4 years of age (prior t

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Thursday, August 22, 2019

Speech by Dr. Amy Abernethy at the National Coordinator for Health IT Third Interoperability Forum - 08/22/2019

Remarks by Dr. Amy Abernethy, Principal Deputy, FDA, at the Office of the National Coordinator for Health IT Third Interoperability Forum in Washington, DC. on August 22, 2019

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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

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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 Blood Grouping Reagents Evaluation

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

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Recommendations for Management of Donors at Increased Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Group O Infection

We, the Food and Drug Administration (FDA), are providing you, blood and plasma establishments, with a revised list of countries that should be included in questions for identifying donors at increased risk for HIV-1 group O infection.

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Donors of Blood and Blood Components: Notification of Donor Deferral, Small Entity Compliance Guide

The Food and Drug Administration (FDA) has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121).

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Availability of FDA’s eSubmitter Program for Regulatory Submissions from Licensed Blood Establishments

We, FDA, the Center for Biologics Evaluation and Research (CBER), are announcing to you, licensed blood establishments that collect Whole Blood and blood components, including Source Plasma, the availability of CBER’s eSubmitter Program (eSubmitter), an electronic submissions program.

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Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture

This is the Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Final Guidance.

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Requalification of Donors Previously Deferred for a History of Viral Hepatitis after the 11th Birthday

We, FDA, are issuing this guidance to provide you, establishments that collect Whole Blood or blood components intended for transfusion or for further manufacture, including Source Plasma and Source Leukocytes, with recommendations for a requalification method under Title 21 of the CFR.

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Patient Engagement Collaborative

The Patient Engagement Collaborative (PEC) is an advancement in FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Patient Affairs Staff (PAS) in the Office of Clinical Policy and Programs (OCPP).

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Perspectives on In Vitro Diagnostic Devices Regulated by the Office of Blood Research and Review; Public Workshop - 07/15/2019 - 07/16/2019

The purpose of this workshop is to provide an overview of key elements of regulatory submissions for these devices, and to facilitate education and communication between manufacturers and sponsors of these devices and the divisions in CBER that regulate them.

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August 22, 2019 at 01:38PM Society for Social Studies of Science annual meeting

La conférence annuelle de la Society for Social Studies of Science se tient cette année sur le thème "Innovations, Interruptions, Régénérations", avec la participation du Cirad qui présentera ses travaux sur sur la résistance aux antibiotiques et sur les partenariats public-privé en santé animale.



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Wednesday, August 21, 2019

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

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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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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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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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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

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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

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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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Initiatives for Patients to Engage With FDA

A summary of initiatives to allow direct participation by patients and patient advocates to engage with the FDA

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2019 Scientific Computing Days Symposium - 09/09/2019 - 09/10/2019

The 2019 Scientific Computing Days symposium will boast a plethora of scientists, key industry contributors, gathering to help the FDA improve the application of technology, and scientific computing in support of FDA’s public health mission

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Tuesday, August 20, 2019

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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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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4 Tips for a Healthy and Stress-Free Lunchbox

When it comes to thinking up healthy lunches for kids, think outside the lunchbox! Watch this video and then read below for more healthy lunch tips!

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Guidance, Compliance & Regulatory Information (Biologics)

This is region content for the Site Studio Web Site Section 'Guidance, Compliance & Regulatory Information', Region 'MainContent'

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Monday, August 19, 2019

Patient Listening Sessions

Patient Listening Sessions led by FDA’s Patient Affairs Staff provide an opportunity for medical product Centers to engage with patients, caregivers, and their advocates about their experience with a disease or condition.

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FDA Voices: Perspectives From FDA Leadership and Experts

FDA Voices provides expert perspectives and insights into the agency's work on a variety of topics, issues and policies, in the areas of medical products, food, tobacco, policy, and consumer safety and enforcement.

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Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications

Guidance for Industry - Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications, Electronic Submissions

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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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Friday, August 16, 2019

Treating Cushing's Disease in Dogs

FDA approved medications can help manage this disease that most commonly occurs in middle-aged and older dogs.

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Alinity s Chagas

The Alinity s Chagas assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to T. cruzi (the causative agent of Chagas disease) in human serum and plasma specimens on the Alinity s System.

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Thursday, August 15, 2019

Combating Antibiotic Resistance

Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon that reduces or eliminates the effectiveness of antibiotics

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Combating Antibiotic Resistance

Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon that reduces or eliminates the effectiveness of antibiotics

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June 20, 2016: Blood Products Advisory Committee Meeting Announcement - 06/20/2016 - 06/20/2016

On June 20, 2016, the Blood Products Advisory Committee Meeting members will participate in the meeting via teleconference.

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2016 Meeting Materials, Blood Products Advisory Committee

Meeting materials include announcement, agenda, minutes, presentations for the 2016 Blood Products Advisory Committee meetings.

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Wednesday, August 14, 2019

Outsmarting Poison Ivy and Other Poisonous Plants

Poison ivy and other poisonous plants are a hazard year-round. Here are tips for preventing and treating the itchy rash and blisters.

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Labeling and Promotion Guidances

This page lists Labeling and Promotion Guidance documents.

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Tuesday, August 13, 2019

Blood Grouping Reagent, Anti-A (Murine Monoclonal) (FFMU) STN# 125669 & 125680

Intended for Further Manufacturing of Blood Grouping Reagents

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Vaccine Safety & Availability

Vaccine Safety & Availability

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Monday, August 12, 2019

December 08, 2019 at 04:20PM Immune Globulins

Lists of immune globulins fractionated plasma products blood.

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December 08, 2019 at 02:02PM Danger: Don’t Drink Miracle Mineral Solution or Similar Products

After receiving numerous reports of consumers getting sick, the FDA warns you not to drink sodium chlorite products such as Miracle Mineral Solution. These products turn into bleach and can make you sick, the FDA says.

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Legionnaires' disease: Deadly outbreak at Sheraton Atlanta Hotel is a "nationwide problem," attorney says - CBS News

  1. Legionnaires' disease: Deadly outbreak at Sheraton Atlanta Hotel is a "nationwide problem," attorney says  CBS News
  2. Deadly Legionnaires' outbreak at Atlanta hotel is the largest on record in Georgia  CNN
  3. Hundreds may have been exposed in deadly Legionnaires' outbreak  CBS This Morning
  4. View full coverage on Google News


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December 08, 2019 at 10:20AM Safety & Availability (Biologics)

Important information about the safety and availability of biological products.

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Friday, August 9, 2019

September 08, 2019 at 06:05PM Regulatory Harmonization and Convergence

The Agency engages in a range of explicit harmonization initiatives, a subset of which includes the participation of CBER.

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Thursday, August 8, 2019

August 08, 2019 at 05:22PM What happens after a Patient Listening Session?

Learn about what happens after a Listening Session occurs and check out summaries from previous sessions on our website.

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August 08, 2019 at 05:30PM How does FDA benefit from Patient Listening Sessions?

Learn how FDA benefits from Patient Listening Sessions, such as understanding what is important to patients, caregivers, and patient advocates when medical products are being developed.

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August 08, 2019 at 05:30PM Rare Disease Listening Sessions

Patient Listening Sessions led by FDA’s Patient Affairs Staff provide an opportunity for medical product Centers to engage with patients, caregivers, and their advocates about their experience with a disease or condition.

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August 08, 2019 at 05:22PM How do I prepare for a Patient Listening session?

Learn about how you can prepare to participate in a Listening Session. Listening Sessions can be FDA-requested or patient-led.

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August 08, 2019 at 05:22PM How do I request a Patient Listening Session?

Learn about how to request a Listening Session with the FDA to share your experience with a disease or condition.

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August 08, 2019 at 10:46AM Julien Demenois "The IPCC report on climate change and land tallies with CIRAD's position"

The Intergovernmental Panel on Climate Change (IPCC) recently published a special report on climate change and land, the contents of which tally with CIRAD's research and strategic position. For too long, agriculture was seen merely as a greenhouse gas (GHG) emitter, yet it has major potential to mitigate and adapt to climate change, as highlighted by the 4 per 1000 initiative. The IPCC report lists and assesses several possible solutions, in the light of various criteria. Julien Demenois, ecology researcher and 4 per 1000 correspondent at CIRAD, deciphers its contents.



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August 08, 2019 at 10:46AM Julien Demenois « Le rapport du Giec sur les terres et le changement climatique résonne avec la position du Cirad »

Le Groupe intergouvernemental d’experts sur le climat (Giec) vient de publier un rapport spécial et inédit sur les terres et le changement climatique. Le contenu concorde avec les recherches et le positionnement du Cirad. Trop longtemps cantonné au seul rôle d’émetteur de gaz à effet de serre (GES)*, le secteur agricole offre pourtant un fort potentiel pour atténuer et s’adapter au changement climatique comme mis en avant par l’initiative 4 pour 1000. Le rapport liste et évalue, à la lueur de différents critères, plusieurs pistes de solutions. Décryptage avec Julien Demenois, chercheur en écologie et chargé de mission 4 pour 1000 au Cirad.



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Monday, August 5, 2019

August 05, 2019 at 05:36PM 4e conférence internationale sur la sécurité alimentaire mondiale

Organisé avec le soutien du Cirad sur le thème : atteindre la sécurité alimentaire locale et mondiale : à quels coûts ?



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