Thursday, April 30, 2020

Germany's would-be chancellors struggle in Merkel's shadow - Politico

  1. Germany's would-be chancellors struggle in Merkel's shadow  Politico
  2. Merkel warns of risk of new outbreak as Germany lifts lockdown  Al Jazeera English
  3. Positive German coronavirus response stems from leadership  Los Angeles Times
  4. Soccer: Bundesliga to Wait Until May 6 for Restart Update  The New York Times
  5. Europe Prepares for Slow Return to Business as Virus Passes Peak  Bloomberg
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2KPdJrf

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

Trump administration draws up plans to punish China over coronavirus outbreak - CNN

  1. Trump administration draws up plans to punish China over coronavirus outbreak  CNN
  2. Trump Officials Are Said to Press Spies to Link Virus and Wuhan Labs  The New York Times
  3. Intel boss confirms investigation into whether coronavirus outbreak the ‘result of an accident’ at Wuhan lab  Fox News
  4. New York Times: Top administration officials have pushed intelligence agencies to link coronavirus to Chinese labs  CNN
  5. Coronavirus was 'not manmade or genetically modified': U.S. spy agency  Reuters
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/3aQDguI

April 30, 2020 at 08:10PM Safety Labeling Changes -- Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act

Drug Safety

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3bwn3fo

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

Georgia governor drops road test requirement for new driver's licenses - Daily Mail

  1. Georgia governor drops road test requirement for new driver's licenses  Daily Mail
  2. Why Georgia Is Reopening Amid the Coronavirus Pandemic  The Atlantic
  3. Georgia issuing driver's licenses without road tests during coronavirus crisis  Fox News
  4. Kemp poised to lift restrictions, despite warnings of renewed outbreak  Atlanta Journal Constitution
  5. Georgia's Coronavirus Reopening Is a Cautionary Lesson  The New York Times
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2xrzJWg

April 30, 2020 at 07:56PM S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals

International Council on Harmonisation - Safety

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

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

Protests erupt in Lebanon as coronavirus outbreak fuels economic panic - CBS News

  1. Protests erupt in Lebanon as coronavirus outbreak fuels economic panic  CBS News
  2. Lebanon hopes for IMF aid after passing crisis plan  Reuters
  3. Lebanon Central Bank governor defends role in economic crisis  Al Jazeera English
  4. It’s Reform Or Ruin For Lebanon  Bloomberg
  5. Small protests break out in Lebanese cities in third night of unrest  Reuters
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/35iDKZw

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

Russia’s coronavirus outbreak is getting bad. Even Putin admits it. - Vox.com

Russia’s coronavirus outbreak is getting bad. Even Putin admits it.  Vox.comView Full Coverage on Google News

via Top stories - Google News https://ift.tt/2zJlkWb

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

Georgia Coronavirus Deaths Surpass 1,000; Forecaster Says Will Double By August With Reopening - Forbes

  1. Georgia Coronavirus Deaths Surpass 1,000; Forecaster Says Will Double By August With Reopening  Forbes
  2. Why Georgia Is Reopening Amid the Coronavirus Pandemic  The Atlantic
  3. Black-owned businesses in Georgia struggle as the state reopens  CNN
  4. Kemp poised to lift restrictions, despite warnings of renewed outbreak  Atlanta Journal Constitution
  5. Opinion: Governor, reconsider reopening Georgia  Atlanta Journal Constitution
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2zGJhgF

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

Inmate who gave birth on ventilator dies of Covid-19 - BBC News

  1. Inmate who gave birth on ventilator dies of Covid-19  BBC News
  2. First female federal inmate – who gave birth while on ventilator – dies of coronavirus  USA TODAY
  3. Over 70 percent of tested inmates in federal prisons have coronavirus  New York Post
  4. Terminal Island prison coronavirus outbreak worst in system  Los Angeles Times
  5. A 30-year-old inmate who gave birth while on a ventilator died after testing positive for coronavirus  CNN
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/3aMzxOY

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

Wednesday, April 29, 2020

Half of Americans won't trust contact-tracing apps, new poll finds - Ars Technica

  1. Half of Americans won't trust contact-tracing apps, new poll finds  Ars Technica
  2. Coronavirus outbreak: What are the privacy risks behind 'contact tracing' apps?  Global News
  3. Apple and Google Have Created Software That Will Alert Users When Near Someone With COVID-19  HouseBeautiful.com
  4. Most Americans cannot or will not use COVID-19 contact tracing apps: poll  Yahoo News
  5. Coronavirus: French MPs approve COVID-19 tracing app despite privacy concerns  euronews (in English)
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2Slhau2

More than 80% of hospitalized COVID-19 patients in Georgia last month were black, CDC study finds - CBS News

  1. More than 80% of hospitalized COVID-19 patients in Georgia last month were black, CDC study finds  CBS News
  2. Why Georgia Is Reopening Amid the Coronavirus Pandemic  The Atlantic
  3. More than 80 percent of hospitalized covid-19 patients in Georgia were African American, study finds  The Washington Post
  4. Opinion: Governor, reconsider reopening Georgia  Atlanta Journal Constitution
  5. Kemp poised to lift restrictions, despite warnings of renewed outbreak  Atlanta Journal Constitution
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/35g8qKM

First female federal inmate – who gave birth while on ventilator – dies of coronavirus - USA TODAY

  1. First female federal inmate – who gave birth while on ventilator – dies of coronavirus  USA TODAY
  2. Inmate who gave birth on ventilator dies of Covid-19  BBC News
  3. Terminal Island prison coronavirus outbreak worst in system  Los Angeles Times
  4. Federal inmate who gave birth while on ventilator dies from coronavirus  NBC News
  5. Coronavirus kills its first female federal inmate weeks after she had an emergency C-section  Washington Post
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/3bQee0c

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 11:57PM S6 (R1) Addendum: Preclinical Safety Evaluation of Biotechnology - Derived Pharmaceuticals

Guidance for Industry

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

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

'It’s horrific': coronavirus kills nearly 70 at Massachusetts veterans' home - The Guardian

  1. 'It’s horrific': coronavirus kills nearly 70 at Massachusetts veterans' home  The Guardian
  2. Nearly 70 veterans killed in 'horrific' outbreak at Massachusetts elder care facility  Fox News
  3. Coronavirus kills nearly 70 veterans at Massachusetts elder care facility  New York Post
  4. Almost every day has brought a new death from coronavirus at the Soldiers’ Home in Holyoke; 67 have died so far  The Boston Globe
  5. Death toll rises to 76 at a Massachusetts veterans care home  Daily Mail
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2yXjO20

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

Fauci says US will have needed tests by end of May, beginning of June | TheHill - The Hill

  1. Fauci says US will have needed tests by end of May, beginning of June | TheHill  The Hill
  2. Dr. Anthony Fauci stresses importance of partnering with states  CNN
  3. Dr. Anthony Fauci warns US could 'be in for a bad fall' if coronavirus treatments don't work  CNBC
  4. Fauci says coronavirus-like outbreak is 'what keeps me up at night'  NBC News
  5. Dr. Anthony Fauci warns ‘we may have to go without’ sports because of coronavirus  NJ.com
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/3d1DCAn

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

Tuesday, April 28, 2020

South Korean office had a coronavirus outbreak — see its seating chart - Business Insider - Business Insider

South Korean office had a coronavirus outbreak — see its seating chart - Business Insider  Business InsiderView Full Coverage on Google News

via Top stories - Google News https://ift.tt/2zFmAcR

Fauci says coronavirus-like outbreak is 'what keeps me up at night' - NBC News

  1. Fauci says coronavirus-like outbreak is 'what keeps me up at night'  NBC News
  2. Dr. Anthony Fauci warns US could 'be in for a bad fall' if coronavirus treatments don't work  CNBC
  3. Virus will return in fall, Fauci says  Reuters
  4. Dr. Fauci Backed Controversial Wuhan Lab with Millions of U.S. Dollars for Risky Coronavirus Research  Newsweek
  5. Trump again says virus is "going to go away," contradicting his health experts  CBS News
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2VJunyI

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

Howard Stern suggests Trump supporters take disinfectants and drop dead - Fox News

  1. Howard Stern suggests Trump supporters take disinfectants and drop dead  Fox News
  2. Americans support state restrictions on businesses and halt to immigration during virus outbreak, Post-U. Md. poll finds  The Washington Post
  3. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/3aHvqn1

Severe storms are likely from Austin to Chicago - CNN

  1. Severe storms are likely from Austin to Chicago  CNN
  2. 50 million Americans at risk for next severe weather outbreak  AccuWeather.com
  3. Severe thunderstorms could bring damaging winds, hail to Dallas-Fort Worth on Tuesday  Fort Worth Star-Telegram
  4. Severe weather threat for 60 million, strong storms likely from Texas to Wisconsin  Fox News
  5. First Alert Day For Possible Severe Storms This Afternoon (4/28)  KWQC-TV6
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2yTseaF

Ohio becomes 11th state to lift coronavirus restrictions as 83million Americans see return to normal - Daily Mail

  1. Ohio becomes 11th state to lift coronavirus restrictions as 83million Americans see return to normal  Daily Mail
  2. Here’s how Gov. Mike DeWine plans to reopen Ohio amid the coronavirus pandemic  cleveland.com
  3. Ohio Gov. DeWine announces first plans to restart economy during coronavirus outbreak  Fox News
  4. Ohio, Michigan governors diverge on plans to reopen during pandemic  Reuters.com
  5. Republican state lawmakers sign on to plan calling for immediate and full re-opening of Ohio businesses  cleveland.com
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/3eYl5Xh

California men accused of peddling millions of nonexistent masks in alleged coronavirus scam - NBC News

  1. California men accused of peddling millions of nonexistent masks in alleged coronavirus scam  NBC News
  2. Two Inland Empire men accused in $4-million scam to sell N95 masks  Los Angeles Times
  3. California men accused of trying to sell millions of nonexistent medical masks | TheHill  The Hill
  4. California pair arrested in alleged PPE-selling scam amid coronavirus outbreak  ABC News
  5. 2 Sought $4 Million for Face Masks That Didn’t Exist, U.S. Says  The New York Times
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2SaHhDF

Angered by criticism, Kemp defends handling of coronavirus outbreak - Atlanta Journal Constitution

  1. Angered by criticism, Kemp defends handling of coronavirus outbreak  Atlanta Journal Constitution
  2. Georgia Restaurants Opened Their Doors Today — Here’s How It Went  Forbes
  3. Reopen or stay closed: Georgia restaurants face a hard choice  Washington Post
  4. Atlanta restaurant dining rooms reopened Monday to mixed feelings  Atlanta Journal Constitution
  5. Trump's angry words to Georgia governor reverberate in state capitals as governors move to reopen states  CNN
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2yL43vl

California men accused of peddling millions of nonexistent masks in alleged coronavirus scam - NBC News

  1. California men accused of peddling millions of nonexistent masks in alleged coronavirus scam  NBC News
  2. Two Inland Empire men accused in $4-million scam to sell N95 masks  Los Angeles Times
  3. California men accused of trying to sell millions of nonexistent medical masks | TheHill  The Hill
  4. California pair arrested in alleged PPE-selling scam amid coronavirus outbreak  ABC News
  5. 2 Sought $4 Million for Face Masks That Didn’t Exist, U.S. Says  The New York Times
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2SaHhDF

Monday, April 27, 2020

Angered by criticism, Kemp defends handling of coronavirus outbreak - Atlanta Journal Constitution

  1. Angered by criticism, Kemp defends handling of coronavirus outbreak  Atlanta Journal Constitution
  2. Reopen or stay closed: Georgia restaurants face a hard choice  Washington Post
  3. Georgia Restaurants Opened Their Doors Today — Here’s How It Went  Forbes
  4. The Jolt: Conspiracy theories thrive in an information vacuum  Atlanta Journal Constitution
  5. Trump's angry words to Georgia governor reverberate in state capitals as governors move to reopen states  CNN
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2yL43vl

Brazil emerges as next potential coronavirus hotspot - New York Post

  1. Brazil emerges as next potential coronavirus hotspot  New York Post
  2. Brazil sees spike in coronavirus cases, with some hospitals overloaded  Fox News
  3. The Coronavirus Crisis in Bolsonaro’s Brazil  The New Yorker
  4. Coronavirus updates: Brazil emerging as potentially next big hot spot as death toll worldwide tops 200,000  Chicago Tribune
  5. Experts: Brazil might be the world’s next outbreak hot spot  The Mercury News
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/3bJBpt3

Colorado and Nevada join Western States Pact as states work on unified coronavirus strategy - CNN

  1. Colorado and Nevada join Western States Pact as states work on unified coronavirus strategy  CNN
  2. Nevada, Colorado join West Coast reopening alliance  POLITICO
  3. In CA: Colorado and Nevada join forces with the West Coast  USA TODAY
  4. Colorado and Nevada join western states cooperating on reopening | TheHill  The Hill
  5. Colorado, Nevada Join Western States Pact to Fight Coronavirus Outbreak  U.S. News & World Report
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2W5khXY

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

'Another pandemic': In Latin America, domestic abuse rises amid lockdown - Reuters

  1. 'Another pandemic': In Latin America, domestic abuse rises amid lockdown  Reuters
  2. 'Another pandemic': Domestic abuse calls spike in Latin America during coronavirus lockdown  NBCNews.com
  3. Fewer domestic violence calls during COVID-19 outbreak has California officials concerned  ABC News
  4. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2YbxRMm

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 27, 2020 at 03:37PM Patient-Focused Drug Development: Methods to Identify What Is Important to Patients Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders

Procedural Guidance

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2n4ewfK

Coronavirus updates: Spain lets children play as US states move to reopen at various speeds - Chicago Tribune

  1. Coronavirus updates: Spain lets children play as US states move to reopen at various speeds  Chicago Tribune
  2. Spain Just Allowed Children to Play Outside for the First Time in 6 Weeks  TIME
  3. Virus Outbreak: News and Analysis From April 27  Bloomberg
  4. Spain daily coronavirus death toll lowest in weeks: Live updates  Al Jazeera English
  5. Spain's daily death toll drops below 300 as children allowed out for first time in weeks – as it happened  The Guardian
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2S6S7dR

General Motors suspends dividend to preserve cash as coronavirus outbreak disrupts production - CNBC

  1. General Motors suspends dividend to preserve cash as coronavirus outbreak disrupts production  CNBC
  2. GM suspends its dividend and stock repurchases to preserve cash  MarketWatch
  3. GM suspends dividend, share buybacks as coronavirus hits sales  Yahoo Finance
  4. GM Stock Dividend, Buybacks Suspended To Preserve Cash GM Suspends Dividend, Stock Buybacks To Conserve Cash  Investor's Business Daily
  5. General Motors Scraps Dividend, Buybacks  TheStreet
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2KDxkdY

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

People crowd Southern California beaches despite coronavirus concerns - CNN

  1. People crowd Southern California beaches despite coronavirus concerns  CNN
  2. California morons? Big beach crowds test state's stay-at-home exhortations  msnNOW
  3. Thousands visit beaches as Southern California experiences heat wave amid coronavirus outbreak | TheHill  The Hill
  4. Overcrowding Could Soon Make One California Beach off Limits  U.S. News & World Report
  5. Contrasting images as some California beaches reopen  CNN
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2W2YAHU

Tyson Foods warns that 'the food supply chain is breaking' as plants close - msnNOW

  1. Tyson Foods warns that 'the food supply chain is breaking' as plants close  msnNOW
  2. Meat processing plants across the US are closing due to the pandemic. Will consumers feel the impact?  CNN
  3. 'The Food Supply Chain Is Breaking.' Tyson Foods Warns of Meat Shortage as Plants Close Due to COVID-19  Yahoo News
  4. US Could Be Weeks From Meat Shortages With Shutdowns Spreading  msnNOW
  5. Workers at US meat plants blame coronavirus outbreaks on company policies  New York Post
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2Ybj2Js

Diamond Offshore Drilling files for bankruptcy - Financial Times

  1. Diamond Offshore Drilling files for bankruptcy  Financial Times
  2. Diamond Offshore Files for Bankruptcy Amid Historic Crude Crash  Bloomberg
  3. Diamond Offshore Files for Chapter 11 Bankruptcy  The Wall Street Journal
  4. Offshore oil driller Diamond files for bankruptcy after OPEC-Russia price war, coronavirus outbreak  Fox Business
  5. Diamond Offshore Files for Bankruptcy  Offshore Engineer
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2KyEQ9U

Saturday, April 25, 2020

Coronavirus at meat packing plants worse than first thought, USA TODAY investigation - AberdeenNews.com

  1. Coronavirus at meat packing plants worse than first thought, USA TODAY investigation  AberdeenNews.com
  2. As COVID-19 moves through America's meat processing plants, St. Louis' lone facility knows what's at  KMOV St. Louis
  3. Coronavirus outbreaks triggers call for more protections for meat plant workers | TheHill  The Hill
  4. Coronavirus Closing Meat, Poultry Plants  Newsy
  5. The Push to Process Local is a Positive for Some Pork Producers  AgWeb
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2Y6vv0Y

Worldwide coronavirus death toll passes 200,000: Live updates - CNN International

  1. Worldwide coronavirus death toll passes 200,000: Live updates  CNN International
  2. Coronavirus latest: at a glance  The Guardian
  3. Coronavirus: US death toll passes 50,000 in world's deadliest outbreak  BBC News
  4. US University Tracking Virus' Spread Warns of Layoffs, Cuts  U.S. News & World Report
  5. US coronavirus death toll passes 50000  The-Latest News
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2VULYTn

Coronavirus: Worldwide death toll climbs to 200,000 - BBC News

  1. Coronavirus: Worldwide death toll climbs to 200,000  BBC News
  2. Worldwide coronavirus death toll passes 200,000: Live updates  CNN International
  3. Coronavirus latest: at a glance  The Guardian
  4. US University Tracking Virus' Spread Warns of Layoffs, Cuts  U.S. News & World Report
  5. Coronavirus: US death toll passes 50,000 in world's deadliest outbreak  BBC News
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/353DptH

Friday, April 24, 2020

Coronavirus: US death toll passes 50,000 in world's deadliest outbreak - BBC News

  1. Coronavirus: US death toll passes 50,000 in world's deadliest outbreak  BBC News
  2. US coronavirus death toll will reach 50000 Friday  ABC News
  3. US coronavirus death toll passes 50000  The-Latest News
  4. US University Tracking Virus' Spread Warns of Layoffs, Cuts  U.S. News & World Report
  5. Some states get a taste of normalcy but others take 'whatever steps necessary' to slow coronavirus spread  CNN
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/3bFiWhk

Second US Navy warship hit by major coronavirus outbreak - CNN

  1. Second US Navy warship hit by major coronavirus outbreak  CNN
  2. USS Theodore Roosevelt's entire crew has been tested for coronavirus; over 800 positive, officials say  Fox News
  3. Navy destroyer forced into port as 18 sailors test positive for coronavirus  POLITICO
  4. Another deployed Navy warship, the USS Kidd, copes with a coronavirus outbreak  The Washington Post
  5. Another Navy warship at sea reports a coronavirus outbreak  ABC News
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2S6LbgX

April 24, 2020 at 09:04PM Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies Guidance for Industry

Rare Diseases

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

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

Coronavirus outbreak: Dow Jones board for Friday trading | LIVE - Global News

  1. Coronavirus outbreak: Dow Jones board for Friday trading | LIVE  Global News
  2. Stocks are flat to close out their first losing week in three  CNBC
  3. Hope dashed: Early rally vanishes, leaving Wall Street mixed  Sentinel-Tribune
  4. 5 Top Mid-Cap Stocks Surging Despite Coronavirus Concerns  Yahoo Finance
  5. Stocks end mixed after coronavirus drug did not improve patients  Al Jazeera America
  6. View Full Coverage on Google News


via Top stories - Google News https://ift.tt/2S3TrOF