February 01, 2020 at 12:47AM Oral Immunotherapy

Oral immunotherapy is a medical treatment in which an individual who is allergic to a specific food consumes an increasing amount of the allergen with the goal of reducing the risk of allergic reactions to the food.

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Africa's Worst Locust Plague in Decades Threatens Millions - The Wall Street Journal

1. Africa's Worst Locust Plague in Decades Threatens Millions  The Wall Street Journal
2. Worst locust outbreak in decades ravages East Africa, threatens food supply  CBS News
3. Millions of locusts are swarming all over East Africa  AOL
4. United Nations: East Africa's Locust Outbreak Needs $76M 'By, Actually, Now'  TIME
5. Giant locust swarms the size of MANHATTAN now threatening millions as they devastate crops in east Africa  The Sun
6. View full coverage on Google News

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January 31, 2020 at 11:12PM FDA approves first drug for treatment of peanut allergy for children

FDA approves first drug for treatment of peanut allergy for children
Treatment with this product may be initiated in individuals ages 4 through 17 years with a confirmed diagnosis of peanut allergy and may be continued in individuals 4 years of age and older.

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Chinese Scientist Working on Coronavirus Claims Pets Can Catch Infection - Newsweek

1. Chinese Scientist Working on Coronavirus Claims Pets Can Catch Infection  Newsweek
2. Coronavirus case in Chicago is 1st person-to-person transmission in US  Chicago Tribune
3. Coronavirus updates: The latest news on the outbreak and the global response  NBC News
4. White House creates task force to monitor deadly coronavirus  New York Post
5. Coronavirus: 1st person-to-person transmission in U.S.  New York Daily News
6. View full coverage on Google News

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January 31, 2020 at 10:37PM 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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Samsung may have accidentally revealed when its upcoming Galaxy S20 smartphone will launch - Business Insider - Business Insider

1. Samsung may have accidentally revealed when its upcoming Galaxy S20 smartphone will launch - Business Insider  Business Insider
2. Samsung Suddenly Reveals Galaxy S20 Surprise Release [Updated]  Forbes
3. Samsung Galaxy S20 Early Glimpse  Unbox Therapy
4. All three Samsung Galaxy S20 phones pass through Geekbench with S865 chips, 12GB of RAM - GSMArena.com news  GSMArena.com
5. Galaxy S20 accessories could be delayed due to coronavirus outbreak  PhoneArena
6. View full coverage on Google News

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American, Delta and United airlines suspend most US- China flights amid coronavirus outbreak - CNN

American, Delta and United airlines suspend most US- China flights amid coronavirus outbreak  CNNView full coverage on Google News

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January 31, 2020 at 08:44PM Postapproval Changes to Drug Substances Guidance for Industry

Pharmaceutical Quality/CMC

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Africa's Worst Locust Plague in Decades Threatens Millions - The Wall Street Journal

1. Africa's Worst Locust Plague in Decades Threatens Millions  The Wall Street Journal
2. Worst locust outbreak in decades ravages East Africa, threatens food supply  CBS News
3. Millions of locusts are swarming all over East Africa  AOL
4. United Nations: East Africa's Locust Outbreak Needs $76M 'By, Actually, Now'  TIME
5. Locust plague decimating east Africa threatens to become a humanitarian crisis, UN warns  Daily Mail
6. View full coverage on Google News

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January 31, 2020 at 07:45PM 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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January 31, 2020 at 07:45PM Fluzone High-Dose Quadrivalent

For active immunization of persons 6 months of age and older for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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January 31, 2020 at 07:37PM 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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January 31, 2020 at 07:27PM Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)

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

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January 31, 2020 at 07:24PM Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up

Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up, Guidance, CBER, Biologics

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No pillows, no hot meals: Airlines adopt preventative measures against the coronavirus - CNN

1. No pillows, no hot meals: Airlines adopt preventative measures against the coronavirus  CNN
2. Coronavirus live updates: flight carrying Britons from Wuhan lands in UK  The Guardian
3. Pilots union files suit to halt American Airlines flights to China amid fears of the coronavirus outbreak  CNBC
4. Coronavirus: Flight taking Britons out of Wuhan is delayed - BBC News  BBC News
5. Here are the 20 U.S. airports where health officials are screening for coronavirus  The Washington Post
6. View full coverage on Google News

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Here’s the daring way Europe’s largest fund manager is reacting to the coronavirus outbreak - MarketWatch

1. Here’s the daring way Europe’s largest fund manager is reacting to the coronavirus outbreak  MarketWatch
2. Source: India's economic survey likely to forecast 2020/21 growth at 6%-6.5% - Reuters  FXStreet
3. GBP/USD Soars on BoE, Yen at Risk After WHO Coronavirus Conference  DailyFX
4. Concern about coronavirus in countries with ‘weaker’ health systems led to WHO declaration  MarketWatch
5. Bridgewater's Ray Dalio Shares His Strategy On Minimizing Financial Risks Of Coronavirus Outbreak  Benzinga
6. View full coverage on Google News

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January 30, 2020 at 12:00PM CIRAD and INRAE: ongoing pooling of resources on the international stage

On Monday 27 January 2020, CIRAD President Managing Director Michel Eddi and INRAE CEO Philippe Mauguin officially renewed the CIRAD-INRAE Joint Support Unit for International Relations (UMA-RI) for a further four years, and decided to step up global partnerships between the two organizations.

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Coronavirus live updates: US raises travel warning, Singapore bans Chinese travelers as outbreak spreads - CNBC

1. Coronavirus live updates: US raises travel warning, Singapore bans Chinese travelers as outbreak spreads  CNBC
2. Coronavirus declared global health emergency by WHO  BBC News
3. UK confirms first coronavirus cases as outbreak spreads globally  CNN International
4. W.H.O. Declares Global Emergency as Wuhan Coronavirus Spreads  The New York Times
5. State Department urges against travel to China  POLITICO
6. View full coverage on Google News

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Goldman Sachs expects coronavirus outbreak to weigh on US economic growth this quarter - CNBC

Goldman Sachs expects coronavirus outbreak to weigh on US economic growth this quarter  CNBCView full coverage on Google News

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Coronavirus: Flight taking Britons out of Wuhan is delayed - BBC News - BBC News

1. Coronavirus: Flight taking Britons out of Wuhan is delayed - BBC News  BBC News
2. Coronavirus infections increase, flight carrying passengers from China set to arrive in UK  Fox News
3. No pillows, no hot meals: Airlines adopt preventative measures against the coronavirus  CNN
4. Pilots union files suit to halt American Airlines flights to China amid fears of the coronavirus outbreak  CNBC
5. Coronavirus live updates: first two patients in UK test positive  The Guardian
6. View full coverage on Google News

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Here’s the daring way Europe’s largest fund manager is reacting to the coronavirus outbreak - MarketWatch

1. Here’s the daring way Europe’s largest fund manager is reacting to the coronavirus outbreak  MarketWatch
2. Source: India's economic survey likely to forecast 2020/21 growth at 6%-6.5% - Reuters  FXStreet
3. GBP/USD Soars on BoE, Yen at Risk After WHO Coronavirus Conference  DailyFX
4. Concern about coronavirus in countries with ‘weaker’ health systems led to WHO declaration  MarketWatch
5. AUD/USD Forecast: Unimpressed by inflation and at risk of falling  FXStreet
6. View full coverage on Google News

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January 31, 2020 at 12:22PM Santé globale : un dispositif en réseau d’envergure mondiale est nécessaire

Les maladies infectieuses, telles qu’Ebola, les coronavirus ou les maladies vectorielles, sont en expansion en raison des transformations économiques, politiques et sociales accentuées par les bouleversements climatiques et écologiques globaux. Dans ce contexte, le Cirad propose de construire un dispositif en réseau en santé globale d’envergure mondiale. Objectif : améliorer l’utilisation, par les différents acteurs, des résultats issus de la recherche et des recommandations nationales ou internationales. A découvrir dans le dernier numéro de Perspective.

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January 29, 2020 at 04:21PM DynACof offers quick and open source modelling of agroforestry coffee production

An international team of researchers, coordinated by CIRAD, has developed a modelling tool capable of simulating agroforestry coffee production and its ecosystem services. Parameterized in Costa Rica, the DynACof (Dynamic Agroforestry Coffee) model could help predict the impacts of climate change on plantations and envisage their adaptation through agroforestry. Details of the open source model have just been published in the journal Environmental Modelling and Software .

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American Airlines pilots union sues to stop flights to China amid coronavirus outbreak | TheHill - The Hill

1. American Airlines pilots union sues to stop flights to China amid coronavirus outbreak | TheHill  The Hill
2. Coronavirus: Flight taking Britons out of Wuhan is delayed - BBC News  BBC News
3. U.S. Plans to Evacuate More Americans by Aircraft From Wuhan  The Wall Street Journal
4. British family allowed to board evacuation flight with Chinese wife  The Guardian
5. Pilots union files suit to halt American Airlines flights to China amid fears of the coronavirus outbreak  CNBC
6. View full coverage on Google News

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American Airlines sued over coronavirus by pilot union seeking to cancel US-China flights - Fox News

1. American Airlines sued over coronavirus by pilot union seeking to cancel US-China flights  Fox News
2. Coronavirus: Flight taking Britons out of Wuhan is delayed - BBC News  BBC News
3. American Airlines pilots sue to halt US-China flights amid coronavirus epidemic  CNN International
4. Airlines remove hot food, blankets, magazines and more amid coronavirus outbreak  Fox News
5. Here are the 20 U.S. airports where health officials are screening for coronavirus  The Washington Post
6. View full coverage on Google News

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American Airlines pilots sue to halt US-China flights amid coronavirus epidemic - CNN

1. American Airlines pilots sue to halt US-China flights amid coronavirus epidemic  CNN
2. Airlines remove hot food, blankets, magazines and more amid coronavirus outbreak  Fox News
3. Coronavirus: Britons on Wuhan flights to be quarantined - BBC News  BBC News
4. British family allowed to board evacuation flight with Chinese wife  The Guardian
5. Coronavirus Will Hurt Airline Profits Short Term. Investors’ Best Play Is To Wait Patiently For Stock Prices To Recover.  Forbes
6. View full coverage on Google News

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Stock Market Opens Down On Flu Fears, Fed Remarks; These Two Big Tech Names Show Earnings Power - Investor's Business Daily

1. Stock Market Opens Down On Flu Fears, Fed Remarks; These Two Big Tech Names Show Earnings Power  Investor's Business Daily
2. Dow rises more than 100 points in late comeback, erases a 244-point drop  CNBC
3. Stocks End Day With Push to Gains  The Wall Street Journal
4. Asian markets tumble as fears over virus outbreak spread  The Associated Press
5. Wall Street slides on China virus concerns, Facebook earnings  Investing.com
6. View full coverage on Google News

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January 30, 2020 at 06:01PM CPG Sec. 270.100 Final Container Labels - Allergenic Extracts Containing Glycerin; Reporting Changes

CPG Sec. 270.100 Final Container Labels - Allergenic Extracts Containing Glycerin; Reporting Changes

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January 30, 2020 at 05:57PM CPG 230.120- Human Blood and Blood Products as Drugs

CPG 230.120- Human Blood and Blood Products as Drugs

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January 30, 2020 at 05:53PM CPG Sec. 230.100 Blood and Blood Products - Definitions

CPG Sec. 230.100 Blood and Blood Products - Definitions

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January 30, 2020 at 09:15PM OraQuick Rapid HIV-1 Antibody Test

Allow for a labeling claim for the detection of antibodies to HIV-1 in venipuncture whole blood specimens and to reduce the maximum read time from 60 minutes to 40 minutes.

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January 30, 2020 at 08:29PM OraQuick ADVANCE Rapid HIV-1/2 Antibody Test

Added labeling claim for the detection of HIV-2 antibodies in oral fluid and a change in the name of the device to OraQuick ADVANCE Rapid HIV-1/2 Antibody Test

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January 30, 2020 at 08:16PM NucliSens HIV-1 QT

In conjunction with clinical presentation and other laboratory markers of disease progression for prognostic assessment of HIV-1 infected patients, and for monitoring the effects of anti-retroviral therapy by serial measurements of plasma HIV-1 RNA for pediatric and adult patients with baseline vir

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January 30, 2020 at 04:53PM L’expertise du Cirad présente à Fruitlogistica, le plus grand salon mondial des fruits et légumes frais

Acteur incontournable du salon Fruit Logistica, le Cirad présentera son expertise sur un stand original, à Berlin, du 5 au 7 février. Au-delà de tables rondes et réunions stratégiques, l’institution a également programmé des rencontres de haut niveau avec des professionnels et institutionnels des filières fruits et légumes frais. Un rendez-vous à ne pas manquer. Retrouvez le Cirad Hall 25, stand C04.

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January 30, 2020 at 04:53PM L’expertise du Cirad présente à Fruitlogistica, le plus grand salon mondial des fruits et légumes frais

Acteur incontournable du salon Fruit Logistica, le Cirad présentera son expertise sur un stand original, à Berlin, du 5 au 7 février. Au-delà de tables rondes et réunions stratégiques, l’institution a également programmé des rencontres de haut niveau avec des professionnels et institutionnels des filières fruits et légumes frais. Un rendez-vous à ne pas manquer. Retrouvez le Cirad Hall 25, stand C04.

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Dow Jones Futures: Tesla Stock Skyrockets; Facebook, Microsoft, ServiceNow, Lam Research Are Big Movers - Investor's Business Daily

1. Dow Jones Futures: Tesla Stock Skyrockets; Facebook, Microsoft, ServiceNow, Lam Research Are Big Movers  Investor's Business Daily
2. Stocks close little changed after Fed decision, Apple jumps to record  CNBC
3. Asian markets tumble as fears over virus outbreak spread  The Associated Press
4. GLOBAL MARKETS-Stocks gain on solid results, but virus keeps safe-havens alive  Yahoo Finance
5. Dow Jones Today Propped By Apple, Dow, Boeing; Chips Stocks Mixed, The Fed's Coronavirus Question  Investor's Business Daily
6. View full coverage on Google News

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January 27, 2020 at 09:37PM Fruit Logistica 2020

The world fruit and vegetable trade fair. With the participation of CIRAD.

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January 27, 2020 at 01:53PM Ecology and Evolution of Infectious Diseases Meeting

Co-organized by CIRAD. Four scientific topics will be covered: diversity of host resistance to pathogens, disease control, the crazy life of microbes, and using genomics and immunity to infer pathogen dynamics.

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January 27, 2020 at 01:45PM UNESCO Chair in World Food Systems Annual Symposium

Symposium organized with the support of CIRAD, on the topic of food and biodiversity and links within nature. With contributions from CIRAD's Michel Eddi during the opening and Selim Louafi during the closing session.

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January 30, 2020 at 01:28PM Blood Guidances

This page contains a listing of Blood Guidances guidances.

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January 30, 2020 at 01:19PM Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry

The draft guidance document provides blood establishments that collect blood and blood components with revised recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components.

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Foreigners Airlifted From Chinese City at Heart of Coronavirus Outbreak - The New York Times

1. Foreigners Airlifted From Chinese City at Heart of Coronavirus Outbreak  The New York Times
2. Two hundred Americans to face quarantine in California  BBC News
3. Overnight flight evacuates 201 Americans out of Wuhan  CBS This Morning
4. Plane Carrying 201 Americans Fleeing Coronavirus Outbreak in China Lands in Calif.  PEOPLE.com
5. Americans Evacuated From Coronavirus-Struck China Return Back To The States | NBC Nightly News  NBC News
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Coronavirus: Flight taking Britons out of Wuhan is delayed - BBC News

1. Coronavirus: Flight taking Britons out of Wuhan is delayed  BBC News
2. American, Delta slash China service as coronavirus 'significantly' lowers demand  CNBC
3. El Al to halt all flights to Beijing until March  The Jerusalem Post
4. Hong Kong’s Perfect Crisis  The Atlantic
5. El Al stops China flights due to deadly virus outbreak  The Australian Jewish News
6. View full coverage on Google News

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January 30, 2020 at 12:00PM Le Cirad et INRAE : une mutualisation à l’international renouvelée

Les Présidents directeurs généraux d’INRAE et du Cirad, Philippe Mauguin et Michel Eddi, ont signé ce lundi 27 janvier 2020 le renouvellement pour 4 ans de l’Unité mixte Cirad-INRAE d’Appui aux Relations Internationales (UMA-RI) et décidé de renforcer les partenariats à l’international entre les deux organismes de recherche.

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January 29, 2020 at 11:24PM Ch. 2 - FDA Authority

Ch. 2 - FDA Authority

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January 29, 2020 at 10:41PM 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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January 29, 2020 at 10:34PM Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies

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

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Amid coronavirus outbreak, plane evacuates U.S. citizens from Wuhan, China - CBS News

1. Amid coronavirus outbreak, plane evacuates U.S. citizens from Wuhan, China  CBS News
2. Americans clear health screening after evacuting from Wuhan, China  Los Angeles Times
3. View full coverage on Google News

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January 29, 2020 at 08:47PM Section 8000: General Information

This is the main page for CBER's SOPP Section 8000: General Information.

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January 29, 2020 at 08:03PM Postapproval Changes to Drug Substances Guidance for Industry

Pharmaceutical Quality/CMC

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January 29, 2020 at 07:50PM Recommended Methods for Blood Grouping Reagents Evaluation

This is the draft guidance for Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin, CBER, Biologics

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January 29, 2020 at 07:48PM Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin

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

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January 29, 2020 at 07:35PM Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled “Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II.

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January 29, 2020 at 07:04PM 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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Starbucks Is Not Messing Around With Coronavirus - Newser

1. Starbucks Is Not Messing Around With Coronavirus  Newser
2. WeWork, Starbucks Shut Doors in China as Coronavirus Infections Spread  QuickTake by Bloomberg
3. Starbucks outpaces earnings estimates but warns coronavirus could hit fiscal 2020  CNBC
4. Starbucks Closes More Than 2000 Stores In China Amid Coronavirus Outbreak  NPR
5. Coronavirus: Starbucks closes 2,000 Chinese branches  BBC News
6. View full coverage on Google News

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January 29, 2020 at 04:21PM DynACof : simuler la production de café agroforestier et ses services écosystémiques

Une équipe internationale de chercheurs, coordonnée par le Cirad, a créé un outil de modélisation capable de simuler la production et les services écosystémiques du café agroforestier. Paramétré au Costa Rica, ce modèle, DynACof (Dynamic Agroforestry Coffee), vise à terme à prévoir les impacts des changements climatiques sur les plantations et à imaginer leurs adaptations grâce à l’agroforesterie. Les détails du modèle, accessible en Open source, viennent d’être publiés dans la revue Environmental Modelling and Software .

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January 29, 2020 at 04:23PM Amendment to "Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry"

This guidance, when finalized, will amend the document entitled “Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry” updated January 2016.

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January 29, 2020 at 04:13PM Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers

This is the Draft Guidance for Industry for Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers.

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January 29, 2020 at 03:59PM Agriflu

Active immunization of adults 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine

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Coronavirus could be a problem for Starbucks - Fox Business

1. Coronavirus could be a problem for Starbucks  Fox Business
2. WeWork, Starbucks Shut Doors in China as Coronavirus Infections Spread  QuickTake by Bloomberg
3. Starbucks outpaces earnings estimates but warns coronavirus could hit fiscal 2020  CNBC
4. Starbucks shutters half its China stores, warns of hit from virus  Aljazeera.com
5. Starbucks closes half its China stores during virus outbreak - The Jakarta Post  Jakarta Post
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Report: White House Considering Temporary Ban on All U.S.-China Flights Amid Coronavirus Outbreak - Gizmodo

1. Report: White House Considering Temporary Ban on All U.S.-China Flights Amid Coronavirus Outbreak  Gizmodo
2. United Airlines suspends some flights between US and China as coronavirus spreads  CNN
3. China virus toll passes 130 as U.S. weighs flight ban  Yahoo News
4. United Airlines suspends some flights China starting Feb. 1  CNBC Television
5. United Airlines suspending flights to China as coronavirus outbreak continues  Fox News
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Cordoning the Coronavirus: Countries Limit Travel to China - The New York Times

1. Cordoning the Coronavirus: Countries Limit Travel to China  The New York Times
2. Coronavirus outbreak: Passengers refuse to board flight with Wuhan travelers in 5-hour standoff  New York Post
3. Thailand 'not able to stop the spread' of coronavirus  Washington Examiner
4. Should You Be Worried About the Coronavirus?  The New York Times
5. Coronavirus In The US: What Federal Agencies Are Doing : Shots - Health News  NPR
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Coronavirus outbreak: China's neighbours brace for economic impact - Al Jazeera English

1. Coronavirus outbreak: China's neighbours brace for economic impact  Al Jazeera English
2. CDC tells travelers to avoid China in expanded travel warning as coronavirus spreads  CNBC
3. China sure of slaying 'devil' virus, Hong Kong to cut links  Reuters
4. Coronavirus: How residents cope with life under lockdown in Wuhan  Al Jazeera English
5. Canada's first coronavirus cases are confirmed in husband and wife: officials  Fox News
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Coronavirus: Foreign Office warns against 'all but essential travel' to China - BBC News

1. Coronavirus: Foreign Office warns against 'all but essential travel' to China  BBC News
2. Coronavirus In The US: What Federal Agencies Are Doing : Shots - Health News  NPR
3. Coronavirus outbreak: Passengers refuse to board flight with Wuhan travelers in 5-hour standoff  New York Post
4. WHO admits error in assessment of deadly coronavirus risk  The Hill
5. Bad timing: New virus poses threat to fragile world economy  Washington Post
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January 28, 2020 at 08:06PM 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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United Airlines cancels some China flights due to 'significant decline in demand' as corornavirus spreads - CNBC

1. United Airlines cancels some China flights due to 'significant decline in demand' as corornavirus spreads  CNBC
2. United becomes first US airline to cancel some China flights amid coronavirus travel warnings  USA TODAY
3. Emirates and Etihad Tell Cabin Crew Headed to China to Wear Face Masks and to Stay in Their Hotel Rooms  Paddle Your Own Kanoo
4. United Airlines closely watching coronavirus crisis as stock falls  Chicago Business Journal
5. Emirates advises crew to stay in hotels, avoid crowds in China due to virus outbreak  Reuters
6. View full coverage on Google News

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January 28, 2020 at 06:09PM Industry Supported Scientific and Educational Activities

Guidance for Industry - Industry Supported Scientific and Educational Activities

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January 28, 2020 at 06:07PM Computerized Systems Used in Clinical Investigations

Guidance for Industry - Computerized Systems Used in Clinical Investigations, Compliance

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January 28, 2020 at 03:35PM Multispot HIV-1/HIV-2 Rapid Test

For the detection and differentiation of circulating antibodies associated with HIV-1 and HIV-2 in human plasma and serum, as an aid in the diagnosis of infection with HIV-1 and/or HIV-2

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January 28, 2020 at 03:21PM MedMira Reveal Rapid HIV-1 Antibody Test

Detection of antibodies to HIV-1 in human serum or plasma specimens

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January 28, 2020 at 03:20PM R & B Medical Group Inc. - 596508 - 01/15/2020

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


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January 28, 2020 at 03:09PM MedMira Reveal G2 Rapid HIV-1 Antibody Test

To allow for the addition of a procedural and reagent control line, a change in the packaging of the Colorimetric Detection Agent, and a change in the name of the device to Reveal TM G2 Rapid HIV-1 Antibody Test

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January 28, 2020 at 02:29PM FDA Continues Strong Support of Innovation in Development of Gene Therapy Products

FDA Continues Strong Support of Innovation in Development of Gene Therapy Products

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January 28, 2020 at 01:35PM Recently Issued Guidance Documents

This page lists Recently Issued CBER and Cross-Center Guidance Documents.

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January 28, 2020 at 01:18PM Cellular & Gene Therapy Guidances

This page contains a listing of cellular and gene therapy guidances.

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January 28, 2020 at 01:10PM Human Gene Therapy for Retinal Disorders

Human Gene Therapy for Retinal Disorders, Guidance for Industry, CBER, Biologics

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January 28, 2020 at 01:08PM Human Gene Therapy for Rare Diseases

Human Gene Therapy for Rare Diseases, Guidance for Industry, CBER, Biologics

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January 28, 2020 at 01:07PM Human Gene Therapy for Hemophilia

Human Gene Therapy for Hemophilia, Draft Guidance for Industry, CBER, biologics

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January 28, 2020 at 01:03PM Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up

Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up, Guidance, CBER, Biologics

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January 28, 2020 at 12:58PM Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)

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

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January 28, 2020 at 12:53PM Long Term Follow-up After Administration of Human Gene Therapy Products

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

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Coronavirus outbreak: China issues temporary ban on wildlife trade - Fox News

1. Coronavirus outbreak: China issues temporary ban on wildlife trade  Fox News
2. China Sends Military Aid to Help Fight Coronavirus Outbreak  Newsweek
3. U.S., Canada warn against China travel as virus spreads, markets slide  Reuters
4. Coronavirus origin: Source of novel virus spreading across the globe REVEALED?  Express.co.uk
5. China virus death toll passes 100 as U.S., Canada issue travel warning  Reuters India
6. View full coverage on Google News

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Coronavirus outbreak: China issues temporary ban on wildlife trade - Fox News

Coronavirus outbreak: China issues temporary ban on wildlife trade  Fox NewsView full coverage on Google News

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Asian markets sink on continued worries about China virus - MarketWatch

1. Asian markets sink on continued worries about China virus  MarketWatch
2. Wall Street tumbles as virus fuels economic worry  Reuters
3. Asian shares sink on mounting worries over China outbreak  Washington Post
4. Dow Futures Resilient as Coronavirus Death Toll Soars Above 100  CCN.com
5. Stocks tumble around the world on virus jitters  The Detroit News
6. View full coverage on Google News

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January 28, 2020 at 06:27AM Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations

This the draft guidance Interpreting Sameness Gene Therapy Products Orphan Drug Regulations

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Trump offers China help as virus spreads, markets reel - Reuters

1. Trump offers China help as virus spreads, markets reel  Reuters
2. China Sends Military Aid to Help Fight Coronavirus Outbreak  Newsweek
3. Coronavirus origin: Source of novel virus spreading across the globe REVEALED?  Express.co.uk
4. Trump offers China help as virus spreads, markets reel  Reuters
5. View full coverage on Google News

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January 27, 2020 at 09:48PM Isolex 300 & 300i Magnetic Cell Selection System

Processing autologuous peripheral blood progenitor cell (PBPC) products to obtain a CD 34+ cell enriched population intended for hematopoietic reconstitution after myeloablative therapy in patients with CD 34-negative tumors.

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January 27, 2020 at 09:37PM Salon Fruit Logistica 2020

Rendez-vous mondial du commerce des fruits et légumes. Avec la participation du Cirad.

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January 27, 2020 at 06:51PM Vaccines, Blood & Biologics

From blood to vaccines, FDA protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. Read these Consumer Updates to learn more.

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January 27, 2020 at 06:46PM Consumer Updates

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

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January 27, 2020 at 06:33PM Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products

Draft Guidance for Industry: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products

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January 27, 2020 at 06:53PM Drugs

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

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January 27, 2020 at 06:51PM Vaccines, Blood & Biologics

From blood to vaccines, FDA protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. Read these Consumer Updates to learn more.

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January 27, 2020 at 05:30PM Antimicrobial Resistance Information from FDA

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

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January 27, 2020 at 05:30PM Medical Countermeasure Monitoring and Assessment

FDA guidance and regulatory information, specific FDA projects related to monitoring and assessment of MCMs, ongoing FDA work related to medical product assessment in general, and key efforts relevant to MCM monitoring and assessment outside of FDA

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January 27, 2020 at 05:18PM What to Know and Do About Possible Nitrosamines in Your Medication

Concerned that your medications might contain a substance that could potentially cause cancer? Keep taking your medications, and talk to your doctor. FDA is working with manufacturers to investigate the source of nitrosamines in drugs and whether they pose risks to human health. Have questions?

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January 23, 2020 at 02:27PM CIRAD and CATIE: more than 30 years of cooperation in Central America focusing on the future of rural populations

For more than 30 years, CIRAD and CATIE have been contributing through their joint projects to improving the quality of life of rural populations in Central America. A partnership based on issues that have become critical for the region – climate change, natural resource management, development linked to cocoa- and coffee-based farming systems. The two institutions have renewed their partnership for ten years within the Mesoamerican Scientific Platform for Agroforestry and are pursuing a number of other projects .

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China's Li pledges medical reinforcements as virus toll hits 81 - Reuters

1. China's Li pledges medical reinforcements as virus toll hits 81  Reuters
2. Coronavirus UK map – when will it hit and where have there been tests?  The Sun
3. Coronavirus – Doctors on front line of outbreak break down screaming and crying after days without sleep  The Sun
4. View full coverage on Google News

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January 24, 2020 at 10:09AM CIRAD has relaunched and broadened its scientific partnership with Congo

CIRAD and the Congo Ministry of Research and Innovation recently signed a general cooperation agreement for a renewed partnership centring on research and training. The agreement broadens the existing partnership, which historically centred on forestry development, to cover new fields: agriculture, agrifoods, and human, plant and animal health .

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China coronavirus outbreak: U.S. plans Wuhan evacuations as death toll hits at least 81 today - CBS News

1. China coronavirus outbreak: U.S. plans Wuhan evacuations as death toll hits at least 81 today  CBS News
2. What is coronavirus and how worried should we be about it?  The Guardian
3. China's Haikou city to start 14-day medical observation for tourists from Hubei  Reuters
4. View full coverage on Google News

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January 27, 2020 at 01:53PM Colloque Ecology and Evolution of Infectious Diseases

Co-organisé par le Cirad. 4 thèmes scientifiques seront abordés : la diversité de la résistance de l'hôte aux agents pathogènes, la lutte contre les maladies, la vie des microbes, l'utilisation de la génomique et de l'immunité pour déduire la dynamique des agents pathogènes.

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January 27, 2020 at 01:45PM Colloque annuel de la Chaire Unesco alimentations du monde

Colloque organisé avec le soutien du Cirad sur le thème Alimentations et biodiversité : se relier dans la nature. Avec l'intervention de Michel Eddi lors de l'ouverture et Selim Louafi en conclusion.

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January 22, 2020 at 04:03PM Moonlight disrupts the circadian clock of coffee trees

A study by CIRAD has shown for the first time that despite its very low intensity, moonlight affects coffee trees on a molecular level, and disrupts their circadian clock. It would therefore be in the interests of the horticultural and market garden sectors to control the effect on crops of this type of light. The results of the CIRAD study have just been published in the journal BMC Plant Biology .

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Wuhan hospitals under pressure as coronavirus is 'getting stronger' - Guardian News

1. Wuhan hospitals under pressure as coronavirus is 'getting stronger'  Guardian News
2. In Coronavirus, a ‘Battle’ That Could Humble China’s Strongman  The New York Times
3. U.S. embassy evacuates American citizens from Wuhan amid Coronavirus outbreak  CBS Evening News
4. In Pictures: Coronavirus outbreak in China | China  Aljazeera.com
5. China says coronavirus can spread before symptoms show -- calling into question US containment strategy  CNN
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Coronavirus outbreak in China shuts Hong Kong Disneyland - Fox News

1. Coronavirus outbreak in China shuts Hong Kong Disneyland  Fox News
2. Hong Kong bans entry of visitors from China virus province  Reuters
3. Coronavirus: Hong Kong protesters set fire to planned quarantine building  The Independent
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In Coronavirus, a ‘Battle’ That Could Humble China’s Strongman - The New York Times

1. In Coronavirus, a ‘Battle’ That Could Humble China’s Strongman  The New York Times
2. U.S. embassy evacuates American citizens from Wuhan amid Coronavirus outbreak  CBS Evening News
3. Wuhan hospitals under pressure as China says coronavirus is getting stronger – video  The Guardian
4. Mayor of China's Wuhan Expects Another 1000 Virus Cases in the City  The New York Times
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Coronavirus News Updates: Latest Reports on Deadly Virus - Bloomberg

1. Coronavirus News Updates: Latest Reports on Deadly Virus  Bloomberg
2. Paris cancels Lunar New Year parade over coronavirus  Reuters
3. Chinese Lunar New Year celebrations from around the world  USA TODAY
4. Coronavirus outbreak spurs Paris to cancel Lunar New Year parade, impacts celebrations worldwide  Fox News
5. Indonesia's 'minority within a minority' celebrate Lunar New Year  Reuters
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Chinese government to build massive 1000 bed hospital for coronavirus patients in just one week - The Sun

1. Chinese government to build massive 1000 bed hospital for coronavirus patients in just one week  The Sun
2. China's Coronavirus Keeps Spreading but the WHO Still Won't Declare a Global Emergency  The Daily Beast
3. China coronavirus: Two deaths reported outside Hubei  Aljazeera.com
4. Dr. Robert Siegel: Coronavirus outbreak – What you need to know about health threat  Fox News
5. Coronavirus Death Toll Rises in China as U.S. Reports Second Case  The Wall Street Journal
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