July 31, 2020 at 11:09PM CPG Sec. 280.110- Microbiological Control Requirements-Licensed Anti-Human Globulin and Blood Grouping Reagents

CPG Sec. 280.110- Microbiological Control Requirements-Licensed Anti-Human Globulin and Blood Grouping Reagents

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July 31, 2020 at 11:01PM CPG Sec. 280.100 - Stability Requirements - Licensed In Vitro Diagnostic Products

CPG Sec. 280.100 - Stability Requirements - Licensed In Vitro Diagnostic Products

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July 31, 2020 at 07:42PM Labeling and Promotion Guidances

This page lists Labeling and Promotion Guidance documents.

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July 30, 2020 at 06:18PM OLYMPUS PK Systems Blood Grouping and Phenotyping Reagents

Product approval information is indicated for the in vitro detection and identification of human blood group antigens by direct agglutination.

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July 30, 2020 at 05:25PM CMC and GMP Guidances

This page lists CMC and GMP Guidance documents.

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July 29, 2020 at 03:54PM Covid-19 and food security | Limiting the impact of the crisis on rice value chains in West Africa

Rice plays a strategic role in food security in West Africa, but the region increasingly relies on imports, and local value chains face constraints in terms of technology, finance and coordination. In an article published in Global Food Security , scientists from CIRAD, AfricaRice, and the International Rice Research Institute (IRRI) propose different policy options to reduce the impacts of the COVID-19 pandemic on rice value chains in West Africa. To increase the resilience of local value chains, policymakers need to focus on supporting millers, especially by facilitating their access to credit.



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July 29, 2020 at 11:50PM Dark Chocolate and Milk Allergies

FDA is releasing more information about its study finding that some dark chocolate products contain varying amounts of milk. And you can't always tell that's the case simply by reading the food label.

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July 29, 2020 at 02:48PM Conférence webinaire « Science et défiance »

Organisée par la MSH Sud et le Cirad, cette conférence bénéficie du soutien de la Fondation Agropolis et Inria. Elle abordera les inquiétudes des acteurs de la recherche publique, mais aussi de la société civile sur la relation science/société. Avec 4 témoignages de scientifiques ayant été mobilisés comme expert sur des sujets de société et d'une journaliste scientifique.



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July 28, 2020 at 10:57PM Influenza neuraminidase antigenicity and efficacy in vaccines

Robert Daniels' research project "Influenza neuraminidase antigenicity and efficacy in vaccines".

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July 28, 2020 at 10:44PM Coronavirus (COVID-19) Update: Daily Roundup July 28, 2020

Coronavirus (COVID-19) Update: Daily Roundup

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July 28, 2020 at 06:33PM 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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July 28, 2020 at 04:53PM CBER Reports

This page contains a summary of regulatory, research, and administrative accomplishments for the last 2 fiscal years and related reports.

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July 28, 2020 at 03:09PM BIMO/Team Biologics/Internet Surveillance/Other

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

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July 28, 2020 at 02:55PM Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products Guidance for Industry

Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products
Guidance for Industry

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July 23, 2020 at 08:00PM Multiple Function Device Products: Policy and Considerations

This guidance explains FDA's policy for multiple function device products, including principles, regulatory approach, and examples of the application of these policies.

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July 27, 2020 at 11:37AM International cooperation between France and South Africa: ARC, CIRAD and INRAE sign a tripartite agreement

On Friday 24 July 2020, Dr Shadrack Ralekeno Moephuli, CEO of the ARC (Agricultural Research Council), Michel Eddi, President Managing Director of CIRAD and Philippe Mauguin, Chair and CEO of INRAE signed a 5-year unprecedented tripartite agreement to strengthen and extend existing collaborations between the three organizations. The institutions confirmed their intentions of working together to tackle the challenges facing the southern Africa region and of contributing to the dialogue on global initiatives that is unfolding in the area. The agreement was initialled remotely by video conference, with Aurélien Lechevallier, Ambassador of France to South Africa, as a witness.



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July 27, 2020 at 10:57PM Evaluation of Therapeutic Approaches Based on Genome Editing and Stem Cell Technologies

Zhaohui Ye's research project "Evaluation of Therapeutic Approaches Based on Genome Editing and Stem Cell Technologies".

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July 27, 2020 at 08:58PM 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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July 27, 2020 at 03:59PM Charter of the Allergenic Products Advisory Committee

This is the charter for the CBER Allergenic Products Advisory Committee.

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July 27, 2020 at 11:37AM Coopération internationale France/Afrique du Sud : signature d’un accord tripartite entre l’ARC, le Cirad et INRAE

Vendredi 24 juillet 2020, Dr Shadrack Ralekeno Moephuli, PDG de l’Agricultural Research Council (Afrique du Sud), Michel Eddi, PDG du Cirad et Philippe Mauguin, PDG d’INRAE ont signé, pour la première fois, un accord tripartite pour renforcer et élargir les collaborations existantes entre les trois organismes. Ils affirment également leur volonté de contribuer ensemble aux enjeux se posant à l’échelle régionale de l’Afrique australe et à la réflexion sur les initiatives globales qui s’y développent. L’accord a été paraphé à distance par visioconférence, en présence d'Aurélien Lechevallier, Ambassadeur de France en Afrique du Sud, témoin de la signature.



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July 21, 2020 at 07:57PM Sandrine Dury: "We won't wipe out hunger and malnutrition with our current food systems"

Eradicating hunger and malnutrition by 2030 will mean changing direction and finding ways of reducing the cost of a healthy, varied diet. This is the stage set by the latest FAO report on the state of food security and nutrition in the world. Sandrine Dury, a specialist in food systems with CIRAD, gives us her reaction.



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