May 01, 2020 at 12:17AM Barbecue Basics: Tips to Prevent Foodborne Illness

Barbecuing with friends and family is a warm-weather treat. Help keep bacteria at bay with these food safety tips.

via Consumer Updates RSS Feed https://ift.tt/3d4aoRa

April 30, 2020 at 08:04PM S9 Nonclinical Evaluation for Anticancer Pharmaceuticals

International Council on Harmonisation - Safety

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2YrZwbE

April 30, 2020 at 08:00PM S8 Immunotoxicity Studies for Human Pharmaceuticals

International Council on Harmonisation - Safety

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2Y1POwB

April 30, 2020 at 07:32PM S6(R1) Addendum: Preclinical Safety Evaluation of Biotechnology

S6(R1) Addendum: Preclinical Safety Evaluation of Biotechnology

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2KPv4jM

April 30, 2020 at 06:36PM CPG Sec. 230.100 Blood and Blood Products - Definitions

CPG Sec. 230.100 Blood and Blood Products - Definitions

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2Sg9OHx

April 30, 2020 at 05:44PM Bridging for Drug-Device and Biologic-Device Combination Products

Draft guidance for industry - Bridging for Drug-Device and Biologic-Device Combination Products

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2Z0R5CA

April 30, 2020 at 05:43PM Helpful Questions and Answers about Coronavirus (COVID-19) and Your Pets

During the coronavirus pandemic, you've learned a lot about keeping your family safe. If your family includes pets, you want to keep them safe, too. FDA offers some helpful questions and answers about keeping your pets safe during the pandemic.

via Consumer Updates RSS Feed https://ift.tt/2YrwBo6

April 30, 2020 at 04:55PM Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency

Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3fbXtif

April 29, 2020 at 10:17AM Covid-19 | A crisis highlighting the need to transform food systems

Over and above its impact on health systems, the Covid-19 pandemic is affecting the entire global food system, with an increased risk of food insecurity, several organizations (EU, FAO, OCHA, UNICEF, USAID, WFP, IFAD, World Bank) declared on 21 April*. A panel of 27 experts from IPES-Food, including CIRAD's Nicolas Bricas , has analysed the symptoms and causes of the crisis and the potential solutions. They call for a "food system transformation that builds resilience at all levels" .



via CIRAD - Actualités / News https://ift.tt/3cV0ZLI

April 29, 2020 at 02:21PM Rapport d’activité 2019

Le rapport d’activité 2019 du Cirad est disponible en ligne. Il présente l'essentiel des actions menées par l'organisme avec ses partenaires durant l'année écoulée. Trois nouveautés : un chapitre consacré à la responsabilité sociétale du Cirad, des interviews de partenaires, et un point sur les champs thématiques stratégiques du Cirad. En complément, vous retrouverez un dossier consacré au Sahel.



via CIRAD - Actualités / News https://ift.tt/2W9lRIx

April 30, 2020 at 12:15AM Elemental Impurities in Drug Products Guidance for Industry

Pharmaceutical Quality/CMC

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3bOXuGL

April 30, 2020 at 12:12AM Electronic Submission of Lot Distribution Reports

This is the Electronic Submission of Lot Distribution Reports - Guidance for Industry, CBER, Biologics

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2yZUj03

April 29, 2020 at 11:58PM Electronic Source Data in Clinical Investigations

Guidance for Industry - Electronic Source Data in Clinical Investigations, Procedural

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2YhG01D

April 29, 2020 at 11:12PM 7 Tips for Cleaning Fruits, Vegetables

Fresh produce can become contaminated in many ways, but following these simple steps can help protect you and your family from foodborne illness.

via Consumer Updates RSS Feed https://ift.tt/2YiDIPZ

April 29, 2020 at 08:38PM Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments

There are currently no FDA-approved drugs, including vaccines, to treat or prevent COVID-19. Products that claim to cure, treat, or prevent COVID-19 haven’t been evaluated by the FDA for safety and effectiveness; they might be dangerous to you and your family.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3btZ1kZ

April 29, 2020 at 05:41PM Consumer Updates

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

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/31VUzHA

April 29, 2020 at 04:30PM Tips on Good Nutrition and Using the Updated Nutrition Facts Label During the Coronavirus Pandemic

The coronavirus (COVID-19) pandemic has shifted many of our daily routines, including the ways we eat. Here are some ways to use the Nutrition Facts Label to ensure you and your family are eating healthfully.

via Consumer Updates RSS Feed https://ift.tt/2VMTsch

April 27, 2020 at 05:14PM Covid-19 | The environmental origins of the pandemic

In an op-ed published in Le Monde , 16 heads of French research organisations, members of the Alliance Nationale de Recherche pour l’Environnement (National Research Alliance for the Environment - AllEnvi*), including CIRAD’s Michel Eddi, sound the alarm on the ecological crisis revealed by the Covid-19 epidemic. They stress the role humans play in environmental degradation and highlight the linkage between pandemics and ecosystem degradation. All types of health are in fact linked, say the scientists, ecosystem health, including plant, animal and human health.



via CIRAD - Actualités / News https://ift.tt/2Sz51lt

April 29, 2020 at 02:21PM Rapport d’activité – Faits marquants 2019

Le rapport d’activité 2019 du Cirad est disponible en ligne. il fait la part belle aux résultats scientifiques des chercheurs de l’établissement. Il reprend également l’essentiel de ses actions, menées avec les partenaires, ainsi qu’un dossier sur l’agroécologie qui a été le thème de l’ouvrage de synthèse scientifique que le Cirad a co-publié avec l’AFD.



via CIRAD - Actualités / News https://ift.tt/2YeLyKb

April 29, 2020 at 10:17AM Covid-19 | Une crise qui révèle le besoin de transformer les systèmes alimentaires

L’épidémie de COVID-19, au-delà de son impact sur les systèmes de santé, affecte l’ensemble du système alimentaire, ont alerté plusieurs organisations (UE, FAO, OCHA, UNICEF, USAID, PAM, FIDA, Banque mondiale) le 21 avril* avec un risque accru d’insécurité alimentaire. Un panel de 27 experts de l’IPES-Food, dont Nicolas Bricas du Cirad fait partie, dresse une analyse des symptômes, causes et solutions potentielles en réponse à cette crise. Ils en appellent à une « transformation des systèmes alimentaires porteuse de résilience à tous les niveaux ».



via CIRAD - Actualités / News https://ift.tt/3bNLcON

April 28, 2020 at 05:27PM 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

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2ZCEYhG

April 28, 2020 at 05:18PM Roster of the Blood Products Advisory Committee

This is the Roster of the Blood Products Advisory Committee (BPAC).

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2JHpvD1

April 28, 2020 at 04:53PM 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.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/32B6bAj

April 27, 2020 at 09:52PM eCopy Program for Medical Device Submissions

This guidance explains the eCopy Program for medical device submissions as well as implementation of this program by the FDA.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2RV6LWF

April 27, 2020 at 06:32PM Devices Guidances

This page lists Medical Device Guidance documents.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2SaRU8A

April 27, 2020 at 05:14PM COVID 19 | Aux origines environnementales de la pandémie…

Dans une Tribune publiée dans le Monde , 16 dirigeants d’organismes de recherche français, membres de l’Alliance nationale de recherche pour l’environnement (AllEnvi*), dont Michel Eddi du Cirad, alertent sur la crise écologique que révèle l’épidémie de COVID-19. Ils rappellent le rôle de l’Homme dans la dégradation de l’environnement et mettent en exergue le lien entre pandémie et dégradation des écosystèmes. En effet, toutes les santés sont liées, rappellent les scientifiques, santé des écosystèmes, incluant santé des végétaux, des animaux et des humains.



via CIRAD - Actualités / News https://ift.tt/2VHLDEx

April 27, 2020 at 04:48PM 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

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2Zghta9

April 27, 2020 at 04:35PM Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic

This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, and dietary supplements during a pandemic.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2IYF89t

April 27, 2020 at 03:55PM Pharmacogenomic Data Submissions

Guidance for Industry - Pharmacogenomic Data Submissions - Procedural

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3cQuIp5

April 27, 2020 at 03:53PM 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.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2Yc9luW

April 23, 2020 at 03:42PM La migration rurale en Afrique subsaharienne : Modèles, facteurs, et relation avec la transformation structurelle

L'Afrique subsaharienne a une longue histoire deLes mouvements migratoires nationaux et internationaux font partie intégrante de l’histoire de l'Afrique subsaharienne. Ces mouvements varient d'une région à l'autre et ont évolué considérablement au fil du temps. LCe document Rural migration in sub-Saharan Africade travail, constituequi une étudie de la dynamique et dles facteurs de la migration au sud du Sahara, et accompagne l'atlas "Une Afrique rurale en mouvement ». IssuIl est le fruit d'un partenariat entre le Cirad et l'Organisation des Nations Unies pour l'alimentation et l'agriculture (FAO), ilet a été préparé par le Cirad en collaboration avec le Centre de l’innovation en gouvernance (GovInn) et, avec le soutien financier de la FAO et du Cirad.



via CIRAD - Actualités / News https://ift.tt/3bI5usJ

April 27, 2020 at 03:05PM Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers

Pharmacology / Toxicology

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2MyZNDI

April 27, 2020 at 03:02PM Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring

Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring, Procedural

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2xVfikO

April 20, 2020 at 03:58PM Covid-19 and food security | How Ivory Coast is protecting its local food systems

Has the Covid-19 pandemic triggered risks of basic food shortages in Ivory Coast? The available data are reassuring, although there is some uncertainty about imported goods. An analysis by two economists: Aurélie Carimentrand, from CIRAD, and Ranie-Didice Bah-Koné, from Alassane Ouattara University in Bouaké.

This article is the second in a series on the impact of Covid-19 on food security in tropical countries.



via CIRAD - Actualités / News https://ift.tt/2SblmMZ

April 24, 2020 at 11:52AM Covid-19 and food security | In Brazil, will emergency aid be enough to guarantee access to food for the country's poor?

With the arrival of Covid-19 in Brazil, tens of millions of people living in poverty are again facing hunger. Despite emergency measures announced by the authorities, many of those people could feel the full force of the consequences of the crisis. Analysis by CIRAD's Stéphane Guéneau, public policy specialist, and Catia Grisa, researcher at the University of Rio Grande do Sul.

This article is the third in a series on the impact of Covid-19 on food security in tropical countries .



via CIRAD - Actualités / News https://ift.tt/359z4Fa

April 24, 2020 at 08:50PM Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products

Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products, Draft Guidance, Level 1, CBER, CDER Biologics, Drugs, September 2019

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2M6ENT4

April 24, 2020 at 08:49PM Vaccines Licensed for Use in the United States

The product name and trade name of vaccines licensed for use in the United States.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/35IEpCG

April 24, 2020 at 08:36PM Informed Consent

Informed Consent Information Sheet - Draft Guidance

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2UPMEKY

April 24, 2020 at 08:28PM Industry Supported Scientific and Educational Activities

Guidance for Industry - Industry Supported Scientific and Educational Activities

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/36y2kEE

April 24, 2020 at 07:37PM Minutes of Institutional Review Board (IRB) Meetings

Final FDA guidance for institutions and Institutional Review Boards on minutes of IRB meetings

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2S48mZq

April 24, 2020 at 07:33PM Independent Consultants for Biotechnology Clinical Trial Protocols

Guidance for Industry - Independent Consultants for Biotechnology Clinical Trial Protocols

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2KwpCST

April 24, 2020 at 07:32PM 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

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2VB8eCT

April 24, 2020 at 07:24PM Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies

Guidance for Industry and Investigators - Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies, Drug Safety

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2KuatRR

April 24, 2020 at 05:47PM Male Breast Cancer: Developing Drugs for Treatment

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

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2MExyV2

April 24, 2020 at 06:41PM CPAP Machine Cleaning: Ozone, UV Light Products Are Not FDA Approved

Most CPAPs can be cleaned with soap and water. Follow your CPAP manufacturer's instructions.

via Consumer Updates RSS Feed https://ift.tt/2zu1HBl

April 24, 2020 at 04:59PM Diagast Bundled BLA 125615, 125619 to 125626

Diagast Bundled BLA 125615, 125619 to 125626

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2RGNQi7

April 24, 2020 at 05:22PM S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

International Council on Harmonisation - Safety

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2x5YKpD