Guidance and Other Information of Special Interest to MCM Stakeholders

Information of particular interest to sponsors/applicants of medical countermeasures to treat, prevent, diagnose, and detect chemical, biological, radiological, and nuclear threats and emerging infectious diseases

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MCM-Related Guidance by Date

Guidances and other information of special interest to MCM stakeholders, sponsors and applicants, listed by date

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Plan, Prepare and Protect Your Pet Before, During and After an Emergency

When it comes to planning for emergencies, pet owners should consider their pets too. With some simple preparations now, you can make sure your pet will be protected, safe and healthy, during and after any emergency.

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June 27, 2019 at 01:29PM Rubber, deforestation and smallholders: Hevea genomic selection to the rescue!

Global demand for natural rubber is constantly growing. Boosting smallholder incomes and avoiding extending rubber plantings at the expense of forests will mean intensifying latex production. Varietal improvement is one way of boosting yields. Researchers from CIRAD and their partners recently looked for the first time at a novel technique: genomic selection of Hevea . Their conclusive results were published on 27 June in Industrial Crops and Products, and are due to be put into practice in 2020, by the Institut français du caoutchouc*.

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Alinity s HTLV I/ll

The Alinity s HTLV I/II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to human T-lymphotropic virus Type I and/or human T-lymphotropic virus Type II (anti-HTLV I/HTLV II) in human serum and plasma specimens on the Alinity s System.

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Flucelvax Quadrivalent

For active immunization of children and adolescents 4 years of age and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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CBER Advanced Technologies Program

In regulating the pharmaceutical manufacturing sector, FDA realizes the need for a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality biologics.

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CBER Advanced Technologies Team (CATT)

To provide an interactive mechanism within CBER for prospective innovators/developers of advanced manufacturing technologies to discuss the implementation of these technologies in the development of CBER-regulated products.

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Alinity's HTLV I/ll

The Alinity s HTLV I/II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to human T-lymphotropic virus Type I and/or human T-lymphotropic virus Type II (anti-HTLV I/HTLV II) in human serum and plasma specimens on the Alinity s System.

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June 27, 2019 at 01:29PM Caoutchouc, déforestation et petits planteurs : la sélection génomique de l’hévéa à la rescousse

La demande mondiale en caoutchouc naturel ne cesse d’augmenter. Pour améliorer les revenus des petits planteurs et éviter d’étendre la culture de l’hévéa au détriment des forêts, il faut intensifier la production de latex. L’une des voies d’accroissement des rendements est l’amélioration variétale. Des chercheurs du Cirad et leurs partenaires viennent d’explorer pour la première fois la technique novatrice de sélection génomique sur l’hévéa. Des résultats concluants sont publiés le 27 juin 2019 dans Industrial Crops and Products. L’application de ces travaux est d’ores et déjà prévue en 2020 par l’Institut français du caoutchouc*.

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June 27, 2019 at 01:49PM Le bananier plantain | Enjeux socio-économiques et techniques

Les bananes à cuire et plantain constituent une ressource cruciale pour la sécurité alimentaire et nutritionnelle en Afrique, en Amérique latine et en Asie. Clair et concis, cet ouvrage présente les connaissances et les innovations disponibles sur cette culture ainsi que les atouts et les contraintes de la filière.

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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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Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry

Guidance for Industry: Clinical/Medical

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Perspectives on In Vitro Diagnostic Devices Regulated by the Office of Blood Research and Review/CBER; Public Workshop Draft Agenda

Draft agenda for the public workshop Perspectives on In Vitro Diagnostic Devices Regulated by the Office of Blood Research and Review/CBER;

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Biologics Guidances

This page displays links to Biologics Guidance documents.

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Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2019

Guidance agenda outling guidance documents CBER is planning to publish during calendar year 2018.

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Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2019

This is the list of guidance topics CBER is considering for development during Calendar Year 2019.

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SENIOR STAFF FELLOW – Glycoconjugate Vaccines (Chemist), RG-1320

The FDA’s Center for Biologics Evaluation & Research, Office of Vaccines Research and Review, Division of Bacterial, Parasitic and Allergenic is recruiting to fill a Senior Staff Fellow position to serve as a Principal Investigator in the Laboratory of Bacterial Polysaccharides (LBP).

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June 25, 2019 at 03:36PM Pl@ntNet is launched in Central America

The Pl@ntNet plant recgonition app has been officially launched for Central America, in Costa Rica, by the country's Vice Minister of Science and Technology. Some 3800 Central American flora species can now be identified using the app.

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2019 Meeting Materials, Allergenic Products Advisory Committee

This is the main page for the CBER 2019 Meeting Materials, Allergenic Products Advisory Committee.

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Meeting Materials, Allergenic Products Advisory Committee

This is the Past Meeting Materials, Allergenic Products Advisory Committee (APAC) landing page

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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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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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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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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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Remarks by Dr. Sharpless at the opening of “Our Story,” FDA’s New History Exhibit - 06/25/2019

Remarks by Ned Sharpless, M.D., Acting Commissioner of Food and Drugs, at the opening of “Our Story,” FDA’s New History Exhibit, June 25, 2019, White Oak, MD

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Vaccines and Related Biological Products Advisory Committee November 8, 2018 Meeting Announcement - 11/08/2018 - 11/08/2018

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee November 8, 2018 Meeting Announcement.

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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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Contacts in the Center for Biologics Evaluation & Research (CBER)

List of contact information in the Center for Biologics Evaluation & Research (CBER)

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MCM-Related Counterterrorism Legislation

Since September 11, 2001, federal legislation has been enacted to strengthen the nation’s preparedness for responding to public health emergencies involving chemical, biological, radiological, nuclear (CBRN) as well as emerging infectious disease threats.

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June 25, 2019 at 03:36PM Pl@ntNet est lancé en Amérique centrale

L’application de reconnaissance des plantes Pl@ntNet a été officiellement lancée pour l’Amérique centrale, au Costa Rica, par la vice-Ministre des Sciences et Technologies. 3800 espèces de la flore méso-américaine sont désormais identifiables dans cette région du monde grâce à cette application mobile.

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

June 25, 2019 at 03:36PM Pl@ntNet est lancé en Amérique centrale

L’application de reconnaissance des plantes Pl@ntNet a été officiellement lancée pour l’Amérique centrale, au Costa Rica, par la vice-Ministre des Sciences et Technologies. 3800 espèces de la flore méso-américaine sont désormais identifiables dans cette région du monde grâce à cette application mobile.

via CIRAD - Actualités / News http://bit.ly/2RBAn9d

Vaccine Adverse Event Reporting System (VAERS) Questions and Answers

VAERS is a national vaccine safety surveillance program created as an outgrowth of the National Childhood Vaccine Injury Act of 1986 (NCVIA) and is administered by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC).

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Dangerous severe storm outbreak to continue into Monday over central US - AccuWeather.com

1. Dangerous severe storm outbreak to continue into Monday over central US  AccuWeather.com
2. Storms possible again today, but not as many  AL.com
3. DFW weather: Another Sunday of storms on the way  WFAA
4. Line of storms leaves 1,000 mile path of destruction, impacting four US major cities  CNN
5. Weather takes a toll on parts of metro Atlanta  CBS46 News Atlanta
6. View full coverage on Google News

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Postmarketing Safety Reporting for Combination Products

Draft guidance for industry and FDA staff: Postmarketing Safety Reporting for Combination Products

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Blood Grouping and Phenotyping Reagents

Blood Grouping and Phenotyping Reagents Main Page

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June 18, 2019 at 05:29PM Boosting the sterile insect technique increases its efficiency against mosquitoes

Boosting the sterile insect technique with low doses of biocides transported by sterilised males could improve control of mosquito-borne epidemics, as shown by researchers from CIRAD and INRA, in collaboration with the FAO-IAEA Insect Pest Control Section. Diseases such as dengue, Zika and chikungunya are concerned. The results of this study were published in Communications Biology - Nature.

via CIRAD - Actualités / News http://bit.ly/2XlmpO7

PAHO/WHO Collaborating Center

CBER has been a Pan American Health Organization (PAHO)/World Health Organization (WHO) Collaborating Center for Biological Standardization since 1998, formalizing its commitment to support the work of WHO after decades of scientific contributions.

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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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Description of FDA Forms for Export Certification

Description of FDA Forms for Export Certification

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Zostavax

Product approval information for Zoster Vaccine also know as Zostavax. Zostavax is a FDA licensed vaccine that helps to reduce the risk of getting herpes zoster or shingles in individuals 50 years of age and older.

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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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Section 8100: Communication

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

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Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD) From Plasma-Derived Products

In recent years, questions have been raised concerning the potential risk of variant Creutzfeldt-Jakob disease (vCJD - a rare but fatal brain infection) for recipients of plasma- derived clotting factors.

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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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Biosimilars Guidances

This page lists Biosimilars Guidance documents.

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Cinco consejos para tener unas vacaciones saludables

Al planificar sus próximas vacaciones a la playa, asegúrese de tener un viaje saludable. Tome en cuenta estos cinco consejos sobre la protección solar, los medicamentos, los lentes de contacto, los tatuajes y una buena alimentación.

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June 19, 2019 at 02:49PM Développement en transition: l’évaluation des politiques de développement fondée sur l’économie comportementale

La 1re session d'un séminaire organisé par le Cirad. Deux autres sessions prévues en septembre et en décembre.

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Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation – Screening and Testing of Stool Donors for Multi-drug Resistant Organisms

On June 13, 2019, the Food and Drug Administration (FDA) informed health care providers and patients of the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT). Bacterial infections caused by multi-drug resistant organisms (MDROs) have

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As homeless are suffering, risk of hepatitis, typhus and other diseases is growing - USA TODAY

1. As homeless are suffering, risk of hepatitis, typhus and other diseases is growing  USA TODAY
2. Los Angeles' homeless crisis: too many tents, too few beds  CNN
3. Why on Earth is it so hard to put out toilets for L.A.'s homeless?  Los Angeles Times
4. View full coverage on Google News

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Public Workshop: Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval - 09/08/2016 - 09/08/2016

Public Workshop; Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval Purpose and Scope of the Meeting
The purpose of the public workshop is to identify and discuss scientific considerations and challenges to help inform the development of human cells, tissues, and cellular and tissue-based products (HCT/Ps) subject to premarket approval, including stem cell-based products.

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Alinity s HBsAg and Alinity s HBsAg Confirmatory

The Alinity s HBsAg assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma specimens on the Alinity s System. The Alinity s HBsAg assay is intended to screen individual human donors, including

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June 18, 2019 at 05:29PM Booster la Technique de l’insecte stérile accroît son efficacité contre les moustiques

Booster la Technique de l’insecte stérile à l’aide d’un biocide à faible dose, transporté par les mâles stérilisés, pourrait permettre de mieux contrôler les épidémies transmises par les moustiques, c’est ce que viennent de montrer des chercheurs du Cirad et de l’Inra, en collaboration avec la division FAO-IAEA de lutte contre les insectes nuisibles. Les pathologies telles que la dengue, le zika ou encore le chikungunya sont concernées. Les résultats de cette étude ont été publiés dans Communications Biology - Nature.

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Innovation and Regulatory Science

Innovation and Regulatory Science

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FDA poliovirus assay is faster and more versatile than current assays used in vaccine development and environmental surveillance

Summary of published article for posting on Innovation and Regulatory Science website.

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Clinical Guidances

This page lists Clinical Guidance documents.

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Labeling and Promotion Guidances

This page lists Labeling and Promotion Guidance documents.

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Part 11, Electronic Records; Electronic Signatures - Scope and Application

Guidance for industry on Part 11, Electronic Records; Electronic Signatures -- Scope and Application

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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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June 17, 2019 at 06:11PM Development of innovative alternative crops for production of natural rubber

Une conférence mondiale autour des cultures alternatives pour la production de caoutchouc naturel organisée par le Cirad.

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Alinity s HBsAg and Alinity s HBsAg Confirmatory

The Alinity s HBsAg assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma specimens on the Alinity s System. The Alinity s HBsAg assay is intended to screen individual human donors, including

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June 12, 2019 at 05:32PM The diversity of local dairy products threatened by imports in West Africa

The wide variety of West African dairy products is a cultural asset that is currently under threat. The reason: growing urbanisation, the lack of public support for local production chains and especially international competition from cheap milk powder imports. Recognition of this culinary heritage requires better characterisation of products, techniques and know-how. This dairy tradition could even help to bolster the market and provide a powerful tool for economic development in the region. These findings will be presented during the third edition of the international “Milk, driver of development” symposium, jointly organised by CIRAD, INRA and ISRA.

via CIRAD - Actualités / News http://bit.ly/2XQ8EE9

Pillsbury Best bread flour recalled in ongoing E. coli outbreak - USA TODAY

1. Pillsbury Best bread flour recalled in ongoing E. coli outbreak  USA TODAY
2. Flour sold at Target, Walmart nationwide being recalled due to E. coli  WSAZ-TV
3. Pillsbury flour among latest brands recalled in Delaware after E. coli outbreak  The News Journal
4. View full coverage on Google News

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Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products

Questions and Answers on Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products, CBER, Biologics

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¿Usa un “vaporizador”? Consulte estos consejos de cómo mantener los ‘líquidos electrónicos’ alejados de los niños

Tocar o beber “líquidos electrónicos” por accidente puede ser peligroso, e incluso mortal, para los niños pequeños. Por eso es importante manejar y almacenar estos productos con cuidado, enseñar a los niños a mantenerse alejados de ellos y prepararse para las emergencias. Tome en cuenta estos consejos.

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Do You Vape? See These Tips on How to Keep E-Liquids Away from Children

Accidentally touching or drinking e-liquids can be dangerous and even deadly for young children. So it’s important to handle and store these products carefully, to teach children to stay away from these products, and to be prepared for emergencies. Consider these tips.

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Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4

Guidance for Industry and FDA Staff: Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4

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Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus

This is the Final Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus.

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Requalification Method for Reentry of Donors Who Test Hepatitis B Surface Antigen (HBsAg) Positive Following a Recent Vaccination against Hepatitis B Virus Infection

This guidance document is intended for blood establishments that manufacture Whole Blood and blood components for transfusion or for further manufacture, including Source Plasma and Source Leucocytes.

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“Lookback” for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV

Multiple layers of safeguards, including donor screening and testing, are used to reduce the riskof transmitting infection through blood transfusion.

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Grapefruit Juice and Some Drugs Don't Mix

Grapefruit juice can affect how well some medicines work, and it may cause dangerous side effects.

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Algunos suplementos dietéticos importados y productos medicinales de venta libre pueden hacerle daño

Si compra productos importados comercializados como “suplementos dietéticos” y productos medicinales de venta libre, tenga cuidado. Abundan las estafas de fraude a la salud, particularmente en tiendas internacionales o étnicas, mercados de pulgas, mercados de intercambio y en Internet.

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Cómo usar de manera segura los medidores de glucosa y las tiras reactivas para la diabetes

La Administración de Alimentos y Medicamentos de los Estados Unidos controla los medidores de glucosa y las tiras reactivas. Lea esta información de seguridad de la FDA, incluyendo los consejos en cuanto a por qué no debe comprar ni vender tiras reactivas de segunda mano.

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Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry'

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Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion

This is the Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion.

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Real-Time Premarket Approval Application (PMA) Supplements

Information about the real-time review process for PMA supplements and outlines the procedures for requesting and submitting these types of documents.

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Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients

Guidance for Industry, Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients, CBER, Biologics

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Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes

Blood establishments are required under 21 CFR 610.40(a)(3) and (b) to test donations of human blood and blood components for hepatitis B virus using approved screening tests that are adequate and appropriate for this purpose.

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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

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Application Submissions Guidances

This page lists Application Submissions Guidance documents.

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On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test

This is the Guidance for Industry On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test. Allogeneic, CBER, Biologics

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Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

This is the Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle.

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For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h

Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h , CBER. Blood, Biologics

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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

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Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency

Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency

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Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS

This is the FINAL GUIDANCE for Industry
Revised Recommendations for the
Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS.

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Revised Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS

Revised Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS, CBER, Biologics

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Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of of HIV-1 and HCV

Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV, CBER, Biologics

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Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable

FDA intends to exercise enforcement discretion with respect to its current regulations governing the requirement for informed consent when human specimens are..

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Drugs

Consumer articles about over-the-counter and prescription drugs.

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Cosmetics

Consumer articles about cosmetics.

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Dietary Supplements

Dietary supplements are regulated by the FDA as food, not as drugs. However, many dietary supplements contain ingredients that have strong biological effects which may conflict with a medicine you are taking or a medical condition you may have. Products containing hidden drugs are also sometimes falsely marketed as dietary supplements, putting consumers at greater risk. For these reasons, it is important to consult with a health care professional before using any dietary supplement. Read these Consumer Updates to learn more.

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What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD

The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.

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

Jobs at the Center for Biologics Evaluation and Research (CBER)

CBER has unique opportunities for individuals with backgrounds in science or administration to fill positions involved in the regulation and research of blood, vaccines and therapeutics.

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June 13, 2019 at 03:29PM Selective logging will not be enough to sustain timber production in Amazonia

Amazonian forests are unlikely to provide enough timber to meet current demand over the long term, even with the use of improved logging practices. That is a key finding of a new study led by the Tropical managed Forests Observatory (TmFO), published today in Environmental Research Letters .

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

Measles Outbreak: N.Y. Eliminates Religious Exemptions for Vaccinations - The New York Times

1. Measles Outbreak: N.Y. Eliminates Religious Exemptions for Vaccinations  The New York Times
2. New York ends religious exemptions for vaccines  CNN
3. Assembly passes bill forcing religious groups to vaccinate  New York Post
4. Anti-vaxxers lose minds after religious exemption bill gets pushed through  New York Post
5. An outbreak of good sense: New York State eliminates the religious exemption for vaccines  New York Daily News
6. View full coverage on Google News

via Top stories - Google News https://nyti.ms/2XaTVGz

Aldi flour recall: Company recalls flour over possible E. coli contamination - CBS News

Aldi flour recall: Company recalls flour over possible E. coli contamination  CBS News

More flour is being recalled in an E. coli outbreak that has sickened more than a dozen people in eight states. King Arthur Flour is recalling 14,218 cases of ...

View full coverage on Google News

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2018 Press Announcements - Health Fraud

Examples of FDA Press Announcements that cite health fraud related violations.

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5 Tips for a Healthy Vacation

As you plan your next vacation, make sure your trip is a healthy one. Consider these five tips on sun safety, medications, contact lenses, tattoos, and eating well.

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FDA Voices on Medical Products

FDA Voices on Medical Products

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MACI (Autologous Cultured Chondrocytes on a Porcine Collagen Membrane)

MACI (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement in adults.

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Ensuring Innovation and Competition for Biologics Leads to More Timely Products for Patients

A robust market for safe, effective biosimilar products is crucial – more products on the market increases competition which can lead to more access and reduced health care costs for patients and our nation’s health care system.

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Blood Guidances

This page contains a listing of Blood Guidances guidances.

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Testing for Biotin Interference in In Vitro Diagnostic Devices

Testing for Biotin Interference in In Vitro Diagnostic Devices, Draft Guidance for Industry, CBER, Biologics

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June 13, 2019 at 10:22AM Faire science à part - Politiques d’inclusion sociale et agriculture familiale en Argentine

Un ouvrage sur l'évolution de l'articulation science-politique. L'auteur fonde sa réflexion sur les recherches menées en Argentine dans les années 2000 en faveur de l'inclusion sociale des populations vulnérables et des agriculteurs familiaux en particulier.

via CIRAD - Actualités / News http://bit.ly/2ZlA05g

December 06, 2019 at 02:59PM 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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June 12, 2019 at 05:32PM Afrique de l’Ouest : la diversité des produits laitiers menacée par les importations

La grande diversité de produits laitiers ouest-africains constitue une richesse culturelle qui est aujourd’hui menacée. En cause : l’urbanisation croissante, le faible soutien des pouvoirs publics aux filières locales et surtout la concurrence internationale avec de la poudre de lait importée et bon marché. La reconnaissance de ce patrimoine culinaire passe par une meilleure caractérisation des produits, des techniques et des savoir-faire. Cette tradition laitière pourrait même contribuer à dynamiser le marché et représenter un immense levier de développement économique pour la région. Ces conclusions seront présentées à la 3e édition du Symposium international « Le lait, vecteur de développement », co-organisé par le Cirad, l’Inra et l’Isra.

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June 12, 2019 at 06:24PM Science ouverte au Sud - Enjeux et perspectives pour une nouvelle dynamique

Un colloque organisé par le Cirad, l'IRD et l'Université Cheikh-Anta-Diop. À destination des professionnels de l’information des représentants d’institutions de recherche, des organisations chargées de politiques de recherche, et des chercheurs eux-mêmes souhaitant partager leurs données et leurs publications, ce colloque vise à faciliter le dialogue entre toutes les parties prenantes sur les enjeux de la science ouverte.

via CIRAD - Agenda / Events http://bit.ly/2XF7dIo

June 11, 2019 at 03:33PM International Veterinary Vaccinology Network Conference 2020

Organisée par l'International Veterinary Vaccinology Network, en partenariat avec le Cirad. La conférence portera sur 4 thèmes : les vaccins pour la volaille, pour l'aquaculture, pour les ruminants et pour les porcs.

via CIRAD - Agenda / Events http://bit.ly/2Kii1t0

December 06, 2019 at 12:30PM Quadracel

Indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis. A single dose of Quadracel is approved for use in children 4 through 6 years of age as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series

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December 06, 2019 at 09:34AM TRG Rapid Inquiry Program (TRIP)

TRG Rapid Inquiry Program (TRIP) is a temporary program of the TRG to assist stakeholders with questions about how specific HCT/Ps are regulated.

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November 06, 2019 at 06:35PM Pentacel

For active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease caused by Haemophilus influenzae type b when administered to infants and children 6 weeks through 4 years of age (prior to fifth birthday).

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/31pIIRR

November 06, 2019 at 02:54PM Safety Reporting Requirements for INDs and BA/BE Studies

Guidance for Industry and Investigators - Safety Reporting Requirements for INDs and BA/BE Studies, Drug Safety

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November 06, 2019 at 02:53PM Rare Pediatric Disease Priority Review Vouchers

Draft guidance for industry on rare pediatric disease priority review vouchers

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November 06, 2019 at 02:52PM Rare Diseases: Common Issues in Drug Development Guidance for Industry

Rare Diseases: Common Issues in Drug Development Guidance for Industry

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November 06, 2019 at 02:44PM Master Protocols: Efficient Clinical Trial Design Strategies To Expedite Development of Oncology Drugs and Biologics

Master Protocols: Efficient Clinical Trial Design Strategies To Expedite Development of Oncology Drugs and Biologics

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November 06, 2019 at 11:50AM News & Events (Biologics)

Information on recently posted Web pages, meetings, conferences, and workshops.

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June 11, 2019 at 03:33PM International Veterinary Vaccinology Network Conference 2020

Organisée par l'International Veterinary Vaccinology Network, en partenariat avec le Cirad. La conférence portera sur 4 thèmes : les vaccins pour la volaille, pour l'aquaculture, pour les ruminants et pour les porcs.

via CIRAD - Agenda / Events http://bit.ly/2Iws6zc

November 06, 2019 at 10:35AM University Fertility Laboratory, Inc. - 577584 - 05/30/2019

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)


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October 06, 2019 at 06:20PM Product Development Under the Animal Rule

Animal Rule

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June 06, 2019 at 03:18PM Kodiak Cakes Issues Allergy Alert on Undeclared Milk in Kodiak Cakes Blueberry Chia Energy Waffles 10.72 oz. Product UPC code is 7 05599 01215 0.

Kodiak Cakes of Park City, UT is recalling all lots and codes of Kodiak Cakes Blueberry Chia Energy Waffles 10.72 oz that were on shelf prior to March 5, 2018 because they contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

via FDA Food Safety Recalls RSS Feed http://bit.ly/2K4onfw

June 06, 2019 at 03:17PM Market of Choice Issues Allergy Alert on Undeclared Egg in Sezam Kale Salad

Market of Choice of Eugene, Oregon is recalling Sezam Kale Salad because it may contain undeclared EGG. People who have an allergy or severe sensitivity to Egg run the risk of serious or life-threatening allergic reaction if they consume this product.

via FDA Food Safety Recalls RSS Feed http://bit.ly/2MvlgPG

June 06, 2019 at 03:17PM Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in th

via FDA Food Safety Recalls RSS Feed http://bit.ly/2M1oUAz

June 06, 2019 at 03:20PM Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g Due to High Out of Specification Impurity Results

Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of ten lots of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g. A detailed listing of products and lots is listed below. These products were manufactured by Gland Pharma Ltd. and distributed by Sagent Pharmaceuticals.

via FDA Food Safety Recalls RSS Feed http://bit.ly/31dhZYG

June 06, 2019 at 03:20PM Carnivore Meat Company Issues Voluntary Recall of “Vital Essentials Freeze-Dried Beef Nibblets Entrée for Dogs” Pet Food

Carnivore Meat Company of Green Bay, WI, is voluntarily recalling a limited amount, 73 cases, of “Vital Essentials Freeze-Dried Beef Nibblets Entrée for Dogs” pet food because the products have the potential to be contaminated with Salmonella. The recall includes only the product listed below.

via FDA Food Safety Recalls RSS Feed http://bit.ly/2InrcVC

June 06, 2019 at 03:20PM In Association With Sunshine Mills, LIDL Voluntarily Recalls Orlando Brand Grain Free Chicken & Chickpea Superfood Recipe Dog Food Due to Elevated Levels of Vitamin D.

In association with Sunshine Mills, Lidl is voluntarily recalling specific lots of Orlando brand Grain Free Chicken & Chickpea Superfood Recipe Dog Food because the products may contain elevated levels of Vitamin D.

via FDA Food Safety Recalls RSS Feed http://bit.ly/2HZkoP8

June 06, 2019 at 03:20PM Recall Expansion Smokehouse Pet Products Inc. Recalls All Lots Of “Beefy Munchies” Sold Nationwide Because Of Possible Salmonella Contamination

Smokehouse Pet Products, Inc. of Sun Valley, CA is recalling all sizes and package types of dog treats labeled as “Beefy Munchies,” because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

via FDA Food Safety Recalls RSS Feed http://bit.ly/2ItrdHP

June 06, 2019 at 03:20PM Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

ORTHO-NOVUM 1/35 and 7/7/7 (norethindrone/ethinyl estradiol) Tablets

via FDA Food Safety Recalls RSS Feed http://bit.ly/2JZ1CJ8

June 06, 2019 at 03:20PM Apio, Inc. Voluntarily Recalls Five Skus of Eat Smart Single-Serve Salad Shake Ups™

Apio, Inc. of Guadalupe, California is voluntarily recalling five SKUs of Eat Smart® Single-Serve Salad Shake Ups™ (bowls). The recall comes after the Canadian Food Inspection Agency (CFIA) informed the company that one random sample of Eat Smart Single-Serve Salad Shake Ups Sweet Kale/Chou Frise Do

via FDA Food Safety Recalls RSS Feed http://bit.ly/2HZvvY8

June 06, 2019 at 03:20PM Inspired Organics Issues Voluntary Recall of Organic Nut & Seed Butters Due to Potential Health Risk

Inspired Organics, LLC has issued a voluntary recall of Organic Almond, Peanut, and Tahini Butters due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and o

via FDA Food Safety Recalls RSS Feed http://bit.ly/2Io8Hk3

June 06, 2019 at 03:19PM Redbarn Pet Products Issues Voluntary Recall of Dog Chews

With an extreme abundance of caution, and with the care and concern of pets top of mind, Redbarn Pet Products, LLC of Long Beach, CA is voluntarily recalling a single product, Redbarn’s 7-inch Bully Stick three pack, because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products. No illnesses, injuries or complaints have been reported.

via FDA Food Safety Recalls RSS Feed http://bit.ly/2I1nO3M

June 06, 2019 at 03:19PM The Quaker Oats Company Issues Voluntary Recall of a Small Quantity of Cap’n Crunch’s Peanut Butter Crunch Cereal Distributed to Five Target Stores Due to Possible Health Risk

The Quaker Oats Company, a subsidiary of PepsiCo, Inc., today announced a voluntary recall of a small quantity of Cap’n Crunch’s Peanut Butter Crunch cereal due to the potential presence of Salmonella. While the potentially affected product only reached five specific Target stores and is limited to

via FDA Food Safety Recalls RSS Feed http://bit.ly/2ItPjlF

June 06, 2019 at 03:19PM FDA Announcement of Certain Raw Pet Foods Made by Arrow Reliance Inc., Including Darwin’s Natural Pet Products and ZooLogics Pet Food

The FDA is alerting pet owners to a history of four recalls of and multiple complaints associated with Darwin’s Natural and ZooLogics pet foods, manufactured by Arrow Reliance Inc., dba Darwin’s Natural Pet Products, over the period from October 17, 2016 to February 10, 2018. In each instance, the company recalled these products after being alerted to positive findings of Salmonella and/or Listeria monocytogenes in samples of their raw pet food products.

via FDA Food Safety Recalls RSS Feed http://bit.ly/2I1ye3p

June 06, 2019 at 03:19PM Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not conta

via FDA Food Safety Recalls RSS Feed http://bit.ly/2KvjzPG

June 06, 2019 at 03:19PM Seggiano USA, Inc. Issues Allergy Alert on Undeclared Tree Nuts

Seggiano USA, Inc. of Cheyenne, WY is voluntarily recalling Tuscan Kale Pesto mislabeled with Artichoke & Garlic labels because the labels do not declare tree nuts (cashews). Individuals who have allergies to tree nuts run the risk of a serious life-threatening allergic reaction if they consume the Tuscan Kale Pesto product. No incidents have been reported to date in connection with this issue.

via FDA Food Safety Recalls RSS Feed http://bit.ly/2IpHXzD

June 06, 2019 at 03:19PM Oscor Inc. Issues Recall Product Expansion of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

On September 26, 2018 Oscor notified customers of a recall for certain lots (Recall No. 1035166- 09/07/2018-01-R) of TB Unshrouded Bipolar Pacing Leads. As part of the recall correction activities, Oscor is retrieving any remaining inventory out in the field. The recall scope is being expanded to in

via FDA Food Safety Recalls RSS Feed http://bit.ly/30ETH9R

June 06, 2019 at 03:19PM The Double Cola Company Recalls Select Cases of Its Cherry Ski Product

The Double Cola Company is recalling approximately 200 cases of its Cherry SKI product because they are incorrectly labeled. Only the Cherry SKI products with the new design are being recalled, which were delivered to the southern Illinois, Evansville, IN and Winchester, OH markets.

via FDA Food Safety Recalls RSS Feed http://bit.ly/2I2FTi5

June 06, 2019 at 03:19PM Apace Packaging LLC Issues Voluntary Nationwide Recall of Acyclovir (Lot 19900) Due to Product Mix-up

Apace Packaging LLC is voluntarily recalling one lot of Acyclovir Tablet, USP, 400mg, 50ct Unit Dose, NDC# 50268-061-15, Lot Number 19900, to the Retail level. These products have been recalled due to a product mix-up. A small number of blister cards containing Acyclovir Tablets, 400mg, UD Blister Cards may potentially also include Torsemide, 20mg, Tablets.

via FDA Food Safety Recalls RSS Feed http://bit.ly/2KvrLPT

June 06, 2019 at 03:19PM Wegmans Food Markets, Inc. Issues Allergy Alert on Undeclared Milk in Wegmans Pumpkin Loaf, 11 oz., and Wegmans Placek Coffee Cake, 11 oz. and 22 oz.

Wegmans has initiated a voluntary recall of the following products because they may contain milk not declared on the label.

via FDA Food Safety Recalls RSS Feed http://bit.ly/2WZmraX

June 06, 2019 at 03:19PM Hospira Issues a Voluntary Nationwide Recall for Hydromorphone HCL Injection, USP CII Due to The Potential for Empty or Cracked Glass Vials

Hospira, Inc., a Pfizer company, is voluntarily recalling three lots of Hydromorphone HCl Injection, USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials lot numbers 71330DD (NDC 0409-2634-01), and 691853F and 700753F (NDC 0703-0110-01 – Teva lots) to the hospital/institution level. Hospira, Inc. initiated this recall on February 07, 2018 due to the potential that units from these lots may be empty or cracked at the bottom of the glass vial.

via FDA Food Safety Recalls RSS Feed http://bit.ly/2Kvjsne

June 06, 2019 at 03:19PM Wegmans Issues Voluntary Recall of Fresh Cauliflower Rice, Veggie/Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower

Wegmans Food Markets, Inc. has issued a voluntary recall of fresh Cauliflower Rice, Veggie Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower, sold in the produce department between 12/7/18 and 12/18/18, because it may be contaminated with Escherichia coli

via FDA Food Safety Recalls RSS Feed http://bit.ly/2I2EiJa

June 06, 2019 at 03:18PM Ottogi America, Inc. Issues Allergy Alert On Undeclared Egg In Product

Ottogi America, Inc. of Gardena, California announced today it is recalling 1lb 5.16ounce of Jin Ramen Mild 5pk. (Best Before Aug. 19th 2019) and Jin Ramen Spicy 5pk. (Best Before Aug. 20th 2019) due to undeclared egg as an ingredient on the packages

via FDA Food Safety Recalls RSS Feed http://bit.ly/2JyDo9g

June 06, 2019 at 03:18PM Recall of Bittersweet & Feve Chocolate Bars Due to High Levels of Milk Allergens

Today, Recchiuti Confections (San Francisco, CA) discovered two batches of their Bittersweet Chocolate Bar and two batches of their Feve Chocolate Bar contain high levels of milk protein after FDA sampling. No illnesses have been reported to date. People who have an allergy or severe sensitivity to

via FDA Food Safety Recalls RSS Feed http://bit.ly/2IUAZFn

June 06, 2019 at 04:00PM Science & Research (Biologics)

Listing of research programs conducted by CBER scientists and their published scientific articles classified according to the type of work being done: such as general biologics research, allergenics research, blood research, cellular & gene therapy research, tissue research, vaccines research, and xenotransplantation research.

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

June 06, 2019 at 03:07PM Evaluating Viral Antigens and Antibody Neutralization for HIV/AIDS, Smallpox, and Influenza

A description of Carol Weiss's research program and related publications.

via Whats New Vaccines Blood Biologics RSS Feed http://bit.ly/2WmhK9S

June 06, 2019 at 02:45PM CMC and GMP Guidances

This page lists CMC and GMP Guidance documents.

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June 06, 2019 at 12:05PM General Biologics, Notices, Proposed and Final Rules

General Biologics, Notices, Proposed and Final Rules

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June 06, 2019 at 11:52AM « Le lait, vecteur de développement » : des rencontres internationales pour inventer des filières laitières plus durables et inclusives

150 acteurs du secteur laitier de 25 pays sont attendus pour la 3e édition du symposium « Lait, vecteur de développement » les 12 et 13 juin 2019 à Dakar (Sénégal). Objectif : mettre en relation ces acteurs et favoriser les échanges d’expériences autour de la diversité des modèles de développement laitier. Co-organisée par l’ISRA (Sénégal), le Cirad et l’Inra (France), avec le soutien de la FAO et d’Agreenium, cette édition vise à mobiliser les entreprises de transformation et les pouvoirs publics pour accompagner l’essor de la production de lait local en Afrique de l’Ouest. Elle mettra l’accent également sur le rôle des femmes et des éleveurs les plus modestes dans ces dynamiques laitières.

via CIRAD - Actualités / News http://bit.ly/2K18XIZ

June 05, 2019 at 05:09PM Global Landscape Forum

Avec la participation du Cirad

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May 29, 2019 at 09:27AM A decade to boost the synergies between family farming and agro-ecology

Family farmers are central to transitions linked to food security, biodiversity and climate change. According to the FAO definition, family farming accounts for 90% of the world's farms, produces roughly two thirds of its food, and covers more than half its agricultural land. In recognition of this major role, and after the success of an international year in 2014, the United Nations are now dedicating an entire decade to family farms. CIRAD attended the official launch, at FAO HQ in Rome on 29 May.

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