May 29, 2020 at 10:53PM Studies on the Safety and Efficacy of Plasma-derived Products and Their Recombinant Analogs

A description of Basil Golding's research program and related publications.

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May 29, 2020 at 10:13PM Improving Safety and Potency Testing of Allergen Extracts

A description of Jay Slater's research program and related publications.

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May 29, 2020 at 09:58PM Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19

There are no FDA-approved coronavirus preventions or treatments. Researchers are studying new drugs, and drugs approved for other conditions, as possible preventions or treatments for COVID-19. The language describing possible preventions or treatments can be confusing. Here’s what those terms mean.

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May 29, 2020 at 09:58PM Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19

There are no FDA-approved coronavirus preventions or treatments. Researchers are studying new drugs, and drugs approved for other conditions, as possible preventions or treatments for COVID-19. The language describing possible preventions or treatments can be confusing. Here’s what those terms mean.

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May 28, 2020 at 04:52PM Covid-19 and food security | In Madagascar, the milk trade has dried up

In the countries of the global South, certain agricultural value chains are feeling the consequences of the health crisis caused by the Covid-19 pandemic more than others. The dairy chain in Madagascar is a good example. The country's milk producers and dairies are highly dependent on reliable transport services and demand, and they are finding things difficult. An analysis by a group of researchers from CIRAD based on the island, with their partners from FIFAMANOR.

This article is the sixth in a series focusing on the impacts of Covid-19 on food security in tropical countries.



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Thursday, May 28, 2020

May 28, 2020 at 07:46PM 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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May 28, 2020 at 04:52PM Covid & Sécurité alimentaire | A Madagascar, le lait ne s’écoule plus

ans les pays du Sud, certaines filières agricoles ressentent davantage que d’autres les conséquences de la crise sanitaire liée à l’épidémie de Covid-19. C’est le cas de la filière laitière à Madagascar. Fortement dépendante de la fluidité des transports et de la demande, les producteurs de la filière et les laiteries malgaches sont en difficulté. Une analyse par un groupe de chercheurs du Cirad en poste sur l’île avec leurs partenaires malgaches du Fifamanor.

Cet article est le sixième d’une série consacrée aux impacts du Covid-19 sur la sécurité alimentaire de plusieurs pays tropicaux.



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Wednesday, May 27, 2020

May 28, 2020 at 02:45AM Coronavirus (COVID-19) Update: Daily Roundup May 27, 2020

Coronavirus (COVID-19) Update: Daily Roundup

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May 28, 2020 at 12:48AM Coronavirus (COVID-19) Update: FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection

FDA new step to support the evaluation of diagnostic tests for COVID-19, by providing a SARS-CoV-2 reference panel. Reference panels are needed to ensure the quality of the tests, validation of new assays, test calibration, and monitoring of assay performance.

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May 27, 2020 at 10:32PM YESCARTA (axicabtagene ciloleucel)

YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

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May 27, 2020 at 09:27PM DG Gel 8 ABO/Rh (2D)

The DG Gel 8 ABO/Rh (2D) card is for the determination of ABO forward and reverse group, and RhD antigen on the surface of red blood cells of human blood samples. For use with the DG Gel System. For in vitro diagnostic use.

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May 27, 2020 at 06:55PM Blood Safety: Developing Methods to Reduce Infectious Agents in Blood and Related Products and Identifying Biomarkers of Stored Blood Cells

A description of C. D. Atreya's research program and related publications.

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May 27, 2020 at 06:40PM Evaluation of Safety and Potency of Viral Vaccines Based on Analysis of Molecular Consistency

A description of Konstantin Chumakov's research program and related publications.

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May 27, 2020 at 06:30PM Impact of Immunity Induced by Viral and DNA Products

A description of Suzanne Epstein's research program and related publications.

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May 27, 2020 at 02:35PM Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements

Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements Guidance for Industry
Posted May 1998

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May 26, 2020 at 03:20PM Montgomery Women's Medical Center PC dba Montgomery Fertility Center - 607345 - 05/14/2020

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

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May 26, 2020 at 02:19PM Investigational COVID-19 Convalescent Plasma

FDA is issuing this guidance to provide recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency.

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May 20, 2020 at 04:58PM Covid-19 | Using chaos theory to predict the course of the epidemic

How can we predict the course of an epidemic when data are in short supply? To answer that question, a team of scientists has developed an approach based on chaos theory. The results bear out field data, and the approach is due to be rolled out in Africa and also used for other diseases.



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May 25, 2020 at 08:21AM Why are current policies to combat deforestation doomed to failure?

While national and international efforts to reverse the trend of deforestation have multiplied in recent years, there is still no clear evidence to suggest these initiatives are actually working, according to a paper published in One Earth (Cell Press) this week. The international team behind the paper, led by Claude Garcia from CIRAD and ETH Zurich, are calling for a radically new approach that focuses on how we understand individuals make their choices about forest and natural resource management.



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Sunday, May 24, 2020

May 25, 2020 at 08:21AM Pourquoi les politiques actuelles de lutte contre la déforestation sont-elles vouées à l’échec ?

Si les efforts nationaux et internationaux se sont multipliés ces dernières années en matière de lutte contre la déforestation, rien ne prouve que ces initiatives fonctionnent. C’est ce qu’affirme un article qui vient d’être publié dans One Earth (Cell Press). Coordonnée par Claude Garcia du Cirad et de l'ETH Zurich, l’équipe internationale, à l'origine de cette publication, en appelle à une approche radicalement nouvelle, qui se concentre sur la façon dont nous appréhendons les choix individuels relatifs à la gestion des forêts et des ressources naturelles.



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Friday, May 22, 2020

May 22, 2020 at 08:03PM Identification of Targets for Development of Vaccines and Biological Therapies Against Gastrointestinal Pathogens

Identification of Targets for Development of Vaccines and Biological Therapies Against Gastrointestinal Pathogens

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May 22, 2020 at 07:40PM Vaccines Research

List of Vaccines Research.

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May 22, 2020 at 04:56PM Cellular, Tissue and Gene Therapies Advisory Committee May 8, 2020 Meeting Announcement - 05/08/2020 - 05/08/2020

This is the main page for the CBER Cellular, Tissue and Gene Therapies Advisory Committee May 8, 2020 Meeting Announcement.

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May 22, 2020 at 04:00PM North Coast Biologics - 607532 - 05/21/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

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May 20, 2020 at 05:50PM Biodiversity | A tool to assess mangrove restoration

Mangroves are some of the richest ecosystems in terms of biodiversity. They are now attracting growing interest for their ecosystem services such as the protection of fauna and flora or coastal defence against rising sea levels or tsunamis. To better protect them, scientists from CIRAD have developed an algorithm to ensure effective, automatic monitoring of stands.



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May 22, 2020 at 08:45AM Can tropical forests stand the heat? Yes, but only up to 32°C

Tropical forests face an uncertain future due to climate change. New research published in Science on 21 May suggests they could continue to store large amounts of carbon in a warmer world, provided countries limit their greenhouse gas (GHG) emissions to keep daytime temperatures below 32°C. The study, coordinated by the University of Leeds, involved an international team of 225 researchers, including four from CIRAD.



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May 20, 2020 at 05:50PM Biodiversité | Un outil pour évaluer la réhabilitation des mangroves

Les mangroves constituent des écosystèmes parmi les plus riches en biodiversité. Elles suscitent désormais un intérêt croissant pour leurs services écosystémiques comme la protection de la faune et la flore ou la défense des côtes face à la hausse des niveaux marins ou aux tsunamis. Pour mieux les protéger, des scientifiques du Cirad ont mis au point un algorithme permettant d’assurer un suivi efficace et automatique des peuplements.



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May 21, 2020 at 11:49PM Donate COVID-19 Plasma

If you have fully recovered from COVID-19, you may be able to help patients currently fighting the infection by donating your plasma. Because you fought the infection, your plasma now contains COVID-19 antibodies.

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May 21, 2020 at 08:38PM Devices Guidances

This page lists Medical Device Guidance documents.

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May 21, 2020 at 06:48PM HCT/P Inspection Information

This is the main page for the CBER HCT/P Inspection Information.

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May 21, 2020 at 07:01PM Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

This policy allows certain modifications to the design and manufacturing of previously approved PMA and HDE devices during the COVID-19 pandemic.

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May 20, 2020 at 06:21PM 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).

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May 20, 2020 at 04:58PM Covid-19 | Quand la théorie du chaos prévoit l’évolution de l’épidémie

Comment prévoir l’évolution d’une épidémie lorsque l’on dispose de peu de données ? Pour répondre à cette question, une équipe de scientifiques de l’IRD et du Cirad a développé une approche fondée sur la théorie du chaos. Les résultats corroborent les données de terrain. Cette approche sera déployée en Afrique mais aussi utilisée pour d’autres maladies.



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