September 30, 2020 at 11:20PM Biological Product Deviation Reporting -- Blood Product Codes

This is the main page for the Biological Product Deviation Reporting - Blood Product Codes.

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September 30, 2020 at 11:16PM Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Non-Blood Product Codes

This is the main page for the Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Non-Blood Product Codes.

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September 30, 2020 at 11:08PM Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Deviation Codes

Use the following list of Biological Product Deviation (BPD) Codes to assign a specific code to a reportable event when you submit the report to FDA. Use the guidance document, "Biological Product Deviation Reporting for Blood and Plasma Establishments," (https://ift.tt/2oKXjsp) to determine if you must report an event. The list includes deviations from regulations, standards, and standard operating procedures (SOPs) that may affect the safety, purity, or potency of a product. These codes may not apply to all establishments because they include deviations and unexpected events related to SOPs implemented at individual establishments and may not be an industry standard or a procedure at your facility. The use of BPD Codes will assist the FDA in analyzing the data submitted and streamline the trend analysis.

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September 30, 2020 at 10:38PM Remarks by Dr. Hahn to the Global Coalition for Regulatory Science Research - 09/30/2020

Remarks by Stephen Hahn, MD, Commissioner of Food and Drugs, to the Global Coalition for Regulatory Science Research, Sept. 30, 2020

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September 30, 2020 at 10:28PM Blood Notices Proposed and Final Rules

List of blood notices, proposed and final rules

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NFL COVID-19 outbreak: Steelers-Titans Week 4 matchup postponed, here's how it could be rescheduled - CBS Sports

1. NFL COVID-19 outbreak: Steelers-Titans Week 4 matchup postponed, here's how it could be rescheduled  CBS Sports
2. Titans, Vikings close facilities after Titans players test positive for the coronavirus | First Take  ESPN
3. These 3 Plays Indicate That Justin Jefferson is the Real Deal  Zone Coverage
4. Titans, Vikings close facilities after positive tests  Reuters
5. Tennessee Titans, Minnesota Vikings close facilities after Titans players test positive for the coronavirus  ESPN
6. View Full Coverage on Google News

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September 30, 2020 at 09:27PM Workshops, Meetings & Conferences (Biologics)

Information on CBER sponsored or co-sponsored meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties.

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September 30, 2020 at 07:25PM Compliance Actions (Biologics)

CBER carries out a wide range of compliance and surveillance activities during the "life cycle" of biological products

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September 30, 2020 at 03:14PM IXINITY

Indicated in adults and children ≥ 12 years of age with hemophilia B for control and prevention of bleeding episodes, and for perioperative management.

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September 30, 2020 at 06:13PM Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

The purpose of this guidance is to provide further clarification and updated information on the use of International Standard ISO 10993-1

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September 28, 2020 at 10:23AM The COVID-19 pandemic must not overshadow mosquito control

While all eyes are on COVID-19, other infectious diseases are spreading dangerously. This is the case for dengue, a disease transmitted by mosquitoes of the genus Aedes . Researchers from several French research organisations have raised the alarm in an article published in Plos NTD on 23 September. Vector control must continue, even in times of pandemic.

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September 29, 2020 at 07:23PM The Facts on Tampons—and How to Use Them Safely

Tampons are medical devices regulated by the U.S. Food and Drug Administration. If you or a loved one uses them, it's important to use them safely. Learn the basics.

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WHO to probe 'sexual exploitation' by aid workers in DR Congo - BBC News

1. WHO to probe 'sexual exploitation' by aid workers in DR Congo  BBC News
2. More than 50 women in DRC allege abuse by Ebola aid workers  The Guardian
3. W.H.O. Workers Are Accused of Sex Abuse During Ebola Response in Congo  The New York Times
4. WHO to probe sex abuse by aid workers in DRC amid Ebola outbreak  Al Jazeera English
5. 50 women accuse WHO aid workers of forcing them to have sex for work during Congo ebola outbreak  Daily Mail
6. View Full Coverage on Google News

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September 30, 2020 at 04:17PM Allergenics Research

List of Immunobiochemistry and Biologics Science & Research for Consumers - Allergenics Research

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September 30, 2020 at 04:13PM Allergenics Guidances

This page contains a listing of Allergenics Guidance documents.

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Tim Benz: Covid-19 infection may not be Titans' fault, but it's also not the Steelers' problem - TribLIVE

1. Tim Benz: Covid-19 infection may not be Titans' fault, but it's also not the Steelers' problem  TribLIVE
2. Titans vs. Steelers could be postponed for additional COVID-19 testing | Get Up  ESPN
3. Titans, Vikings suspend in-person activities after Titans' 8 positive COVID-19 tests  Yahoo Sports
4. Will Covid-19 postpone the NFL season? There are 16bn reasons why it won't  The Guardian
5. Opinion: Tennessee Titans' COVID-19 outbreak doesn't need to spell doom for NFL  msnNOW
6. View Full Coverage on Google News

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September 29, 2020 at 08:05PM It’s a Good Time to Get Your Flu Vaccine

Haven’t had your flu shot yet? It’s not too late. And there are still good reasons to get one.

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September 30, 2020 at 02:08PM Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Announcement - 10/22/2020 - 10/22/2020

This is the CBER Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Announcement.

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September 29, 2020 at 08:05PM It’s a Good Time to Get Your Flu Vaccine

Haven’t had your flu shot yet? It’s not too late. And there are still good reasons to get one.

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NFL COVID-19 outbreak: Mike Tomlin talks potential schedule changes, NFL's plan for Steelers vs. Titans game - CBS Sports

1. NFL COVID-19 outbreak: Mike Tomlin talks potential schedule changes, NFL's plan for Steelers vs. Titans game  CBS Sports
2. Titans, Vikings suspend in-person activities after Titans' 8 positive COVID-19 tests  Yahoo Sports
3. Opinion: Tennessee Titans' COVID-19 outbreak doesn't need to spell doom for NFL  msnNOW
4. First coronavirus outbreak hits the NFL - Sports - WORLD  WORLD News Group
5. Titans facing unprecedented situation with COVID-19 outbreak | NFL Live  ESPN
6. View Full Coverage on Google News

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September 30, 2020 at 11:17AM Fièvre de la Vallée du Rift : un exemple de lutte contre les maladies virales émergentes

Maladie virale à l’origine d’épidémies importantes, principalement en Afrique, la fièvre de la Vallée du Rift (FVR) se transmet du bétail à l’humain. Classée maladie prioritaire émergente par le programme R&D Blueprint de l’Organisation Mondiale de la Santé (OMS) en 2015, sa dynamique de transmission avait pourtant jusqu’ici été peu étudiée. Dans le cadre d’une collaboration multidisciplinaire, des chercheurs et professionnels de la santé publique de l’Inserm, de Santé publique France, du Cirad et de la London School of Hygiene and Tropical Medicine, avec le soutien du consortium REACTing, ont développé un modèle pour étudier la dynamique de l’épidémie de FVR qui a touché Mayotte en 2018-2019 Ces travaux publiés dans la revue PNAS montrent que la transmission du virus à l’humain par le biais des moustiques a été plus importante que la transmission par contact direct avec le bétail infecté . Ils révèlent par ailleurs que vacciner 20 % du bétail pourrait réduire le nombre de cas humains de 30 %.

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Schefter: NFL Hopes To Play Steelers/Titans Sunday, Could Shift Game To Monday Night - Steelers Depot

1. Schefter: NFL Hopes To Play Steelers/Titans Sunday, Could Shift Game To Monday Night  Steelers Depot
2. 2 NFL teams are suspending in-person activities in first Covid-19 disruption of the season  CNN
3. Opinion: Tennessee Titans' COVID-19 outbreak doesn't need to spell doom for NFL  msnNOW
4. Mike Tomlin’s press conference postponed to 6 PM  Behind the Steel Curtain
5. Titans, Vikings Shut Down In-Person Activities After Members Test Positive For Covid-19 | MSNBC  MSNBC
6. View Full Coverage on Google News

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Notre Dame head coach Brian Kelly says Covid-19 'spread like wildfire' on his team - CNN

1. Notre Dame head coach Brian Kelly says Covid-19 'spread like wildfire' on his team  CNN
2. Notre Dame football coach Brian Kelly ties coronavirus outbreak to pregame meal, vomiting player  ESPN
3. Notre Dame's Brian Kelly: Coronavirus outbreak stemmed from team pregame meal  Yahoo Sports
4. Four-star wide receiver Deion Colzie commits to Notre Dame  WNDU-TV
5. ND's Brian Kelly Says Team Dinner Sparked COVID Outbreak, 'Spread Like Wildfire'  TMZ
6. View Full Coverage on Google News

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September 29, 2020 at 09:05PM Remarks by Dr. Hahn to the “Advancing Innovative Science in Generic Drug Development” Workshop - 09/29/2020

Remarks by Stephen Hahn, MD
Commissioner of Food and Drugs
Sept. 29, 20120
White Oak, MD

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Tennessee Titans COVID-19 outbreak - What we know about the positive coronavirus tests; will NFL games be postponed? - ESPN

1. Tennessee Titans COVID-19 outbreak - What we know about the positive coronavirus tests; will NFL games be postponed?  ESPN
2. Titans, Vikings suspend in-person activities after Titans' 8 positive COVID-19 tests  Yahoo Sports
3. Vikings say they’ve had no positive tests  NBC Sports - NFL
4. Tennessee Titans, Minnesota Vikings close facilities after Titans players test positive for the coronavirus  ESPN
5. Vikings Mailbag: Questions on the Titans or Texans games? Submit them here  The Athletic
6. View Full Coverage on Google News

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September 29, 2020 at 08:04PM Spilling the Beans: How Much Caffeine is Too Much?

According to scientists at the FDA, caffeine can be part of a healthy diet for most people, but too much caffeine may pose a danger to your health. Depending on factors such as body weight, medications you may take, and individual sensitivity, “too much” can vary from person to person.

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September 29, 2020 at 07:15PM Antigen Skin Tests

Antigen skin tests are diagnostic tests injected into the skin to aid in the diagnosis of infection with certain pathogens.

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September 29, 2020 at 05:15PM Allergen Patch Tests

Allergen patch tests are diagnostic tests applied to the surface of the skin. Patch tests are used by healthcare providers to determine the specific cause of contact dermatitis,

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September 29, 2020 at 04:56PM Allergen Extract Sublingual Tablets

Sublingual allergen extract tablets are used for treatment only and are also derived from natural substances known to elicit allergic reactions in susceptible individuals, and are intended for the treatment of allergic rhinitis with or without allergic conjunctivitis.

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September 29, 2020 at 04:52PM Allergen Extracts - Injectable

Injectable allergen extracts are used for both diagnosis and treatment and are sterile liquids that are manufactured from natural substances known to elicit allergic reactions in susceptible individuals. Injectable allergen extracts for food allergies are used only for diagnostic purposes. Standardized injectable allergen extracts have an established method to determine the potency (or strength) of the product on a lot-by-lot basis.

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September 29, 2020 at 04:44PM Xenotransplantation

Xenotransplantation is any procedure that involves the transplantation, implantation or infusion into a human recipient of either live cells, tissues, or organs from a nonhuman animal source, or human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues or organs.

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September 29, 2020 at 04:28PM Tissue & Tissue Products

CBER regulates human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient is regulated as a human cell, tissue, and cellular and tissue-based product or HCT/P.

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September 29, 2020 at 04:17PM Science & Research (Biologics)

Listing of research programs conducted by CBER scientists and their published scientific articles classified according to the type of work being done: such as general biologics research, allergenics research, blood research, cellular & gene therapy research, tissue research, vaccines research, and xenotransplantation research.

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September 29, 2020 at 11:29AM Agriculture, richesse et grandes puissances : une nouvelle histoire du développement agricole

C’est un nouveau récit de l’histoire agricole mondiale que nous offre Benoit Daviron avec son ouvrage Biomasse, une histoire de richesse et de puissance. Cet économiste au Cirad retrace, depuis le XVIe siècle, les rapports qu’entretiennent les nations dominantes à l’agriculture, à l’énergie et à la matière. Au travers d’un regard original, l’auteur décrypte les logiques sous-jacentes aux grandes transformations dans l’agriculture pour mieux identifier les leviers d’une transition vers l’agroécologie.

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September 28, 2020 at 10:24PM Guidance, Compliance & Regulatory Information (Biologics)

This is region content for the Site Studio Web Site Section 'Guidance, Compliance & Regulatory Information', Region 'MainContent'

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September 28, 2020 at 09:53PM Importation of Certain FDA- Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act

Guidance for Industry: Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act

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September 28, 2020 at 09:04PM Blood & Blood Products

CBER regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components. FDA has strengthened the safeguards that protect patients from unsuitable blood and blood products and has increased its oversight of the blood industry.

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September 28, 2020 at 07:52PM Allergenics

Lists three types of allergenic products licensed for use: allergen extracts, allergen patch tests, and antigen skin tests. Allergen extracts are used for the diagnosis and/or treatment of allergic diseases such as allergic rhinitis ("hay fever"), allergic sinusitis, allergic conjunctivitis, bee venom allergy and food allergy. Allergen patch tests are diagnostic tests applied to the surface of the skin. Antigen skin tests are diagnostic tests injected into the skin to aid in the diagnosis of infection with certain pathogens.

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September 28, 2020 at 06:54PM FDA's Critical Role in Ensuring Supply of Influenza Vaccine

The U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS) are working toward developing new and better technologies for producing flu vaccines.

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September 28, 2020 at 06:54PM FDA's Critical Role in Ensuring Supply of Influenza Vaccine

The U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS) are working toward developing new and better technologies for producing flu vaccines.

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September 28, 2020 at 06:45PM Vaccines Protect Children From Harmful Infectious Diseases

If you have questions about vaccines, visit the FDA’s guide for parents and caregivers. It describes the routinely administered vaccines for children and provides answers to commonly asked questions.

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September 28, 2020 at 06:48PM Is It a Cold or the Flu? Prevention, Symptoms, Treatments

In much of the Northern Hemisphere, this is prime time for colds, influenza (flu), and other respiratory illnesses. While contagious viruses are active year-round, most infections occur in the fall and winter.

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September 28, 2020 at 06:45PM Vaccines Protect Children From Harmful Infectious Diseases

If you have questions about vaccines, visit the FDA’s guide for parents and caregivers. It describes the routinely administered vaccines for children and provides answers to commonly asked questions.

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September 28, 2020 at 05:45PM VAXELIS

VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae (H. influenzae) type b. VAXELIS is approved for use as a 3 dose series in children 6 weeks through 4 years of age (prior t

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September 28, 2020 at 04:53PM Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act

This guidance describes recommended procedures to obtain a National Drug Code (NDC) for certain FDA-approved prescription drug products that are imported into the United States.

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September 28, 2020 at 04:27PM 510(k) Process (CBER)

510(k) Process (CBER)

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September 28, 2020 at 04:22PM Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry

Guidance for Industry

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September 28, 2020 at 10:23AM La pandémie de COVID19 ne doit pas occulter la lutte contre les moustiques

Alors que tous les regards sont tournés vers la COVID-19, d’autres maladies infectieuses progressent dangereusement. C’est notamment le cas de la dengue, une maladie transmise par les moustiques du genre Aedes . Des chercheurs de plusieurs organismes de recherche français sonnent l’alarme dans un article publié dans Plos NTD le 23 septembre. La lutte anti-vectorielle doit se poursuivre, même en période de pandémie.

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Positive COVID-19 test rates top 25% in some U.S. Midwest states - Reuters

1. Positive COVID-19 test rates top 25% in some U.S. Midwest states  Reuters
2. Wisconsin Is on the Brink of a Major Outbreak  The Atlantic
3. COVID-19 Daily Cases On The Rise In Nearly Half Of U.S. States  NPR
4. New York Cases Top 1000; Midwest Breaks Records: Virus Update  Washington Post
5. Ohio reports 800 new coronavirus cases, 1 new death: Sunday update  cleveland.com
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COVID-19 Daily Cases On The Rise In Nearly Half Of U.S. States - NPR

1. COVID-19 Daily Cases On The Rise In Nearly Half Of U.S. States  NPR
2. Wisconsin Is on the Brink of a Major Outbreak  The Atlantic
3. Four states report record number of new COVID-19 cases | TheHill  The Hill
4. New York Cases Top 1000; Midwest Breaks Records: Virus Update  Washington Post
5. U.S. Midwest sees surge in COVID-19 cases as four states report record increases  Reuters
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Recalled mushrooms linked to salmonella cases across 10 states - Fox News

1. Recalled mushrooms linked to salmonella cases across 10 states  Fox News
2. A multi-state salmonella outbreak that sickened at least 41 people is linked to recalled mushrooms  CNN
3. Mushrooms cause of 10-state Salmonella outbreak, CDC says  Boston 25 News
4. Recalled mushrooms likely linked to salmonella outbreak shipped to restaurants in more than 30 states  USA TODAY
5. A New Salmonella Outbreak Tied to This Ingredient Has Sickened 41 People  Yahoo Lifestyle
6. View Full Coverage on Google News

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Holyoke Soldiers’ Home: Two Charged Over Covid-19 Deaths - The New York Times

1. Holyoke Soldiers’ Home: Two Charged Over Covid-19 Deaths  The New York Times
2. Two charged over handling of deadly COVID-19 outbreak at Massachusetts veterans home  New York Post
3. Criminal charges brought in coronavirus outbreak that killed dozens at Massachusetts veterans’ home  The Washington Post
4. 2 former Holyoke Soldiers’ Home officials face charges in state probe  The Boston Globe
5. Two Men Charged Over Handling of Covid-19 at Massachusetts Veterans’ Home  The Wall Street Journal
6. View Full Coverage on Google News

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September 24, 2020 at 11:44PM Development and Licensure of Vaccines to Prevent COVID-19

This is the Guidance for Industry, Development and Licensure of Vaccines to Prevent COVID-19, CBER, Biologics

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September 24, 2020 at 01:57PM Le Cirad fête la science à Montpellier et sur le web

Cette année, la Fête de la science invite le public à s’interroger sur notre rapport à la nature et notre impact sur l’environnement. Retrouvez les chercheurs du Cirad à Montpellier, mais aussi en ligne !

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September 24, 2020 at 02:48PM Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program

FDA issues final guidance with standards-specific information for biocompatibility testing in the Accreditation Scheme for Conformity Assessment (ASCA) Pilot

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September 24, 2020 at 02:48PM Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program

FDA issues final guidance for standards-specific information on basic safety and essential performance in Accreditation Scheme for Conformity Assessment (ASCA)

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September 24, 2020 at 02:48PM The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program

FDA issues final guidance on the Accreditation Scheme for Conformity Assessment (ASCA) Pilot for Industry, Accreditation Bodies, Testing Laboratories, and FDA

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Study: Less than 1 percent of teachers, students infected since schools reopened | TheHill - The Hill

1. Study: Less than 1 percent of teachers, students infected since schools reopened | TheHill  The Hill
2. Feared coronavirus outbreaks in schools yet to arrive, early data shows  The Washington Post
3. Early data suggests low risk of potential coronavirus transmission in schools: Report  Fox News
4. CPS plan for reopening schools remains unclear as parents share remote learning woes with Board of Education: ‘It’s just not working’  Chicago Tribune
5. 100 N.Y.C. School Buildings Have Already Reported a Positive Case  The New York Times
6. View Full Coverage on Google News

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September 24, 2020 at 12:16AM Coronavirus (COVID-19) Update: Daily Roundup September 23, 2020

Coronavirus (COVID-19) Update: Daily Roundup

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Google Maps now shows you COVID-19 stats - Engadget

1. Google Maps now shows you COVID-19 stats  Engadget
2. Google Maps will show Covid-19 outbreaks  CNBC
3. Google Maps adds an overlay of COVID-19 case trends  The Verge
4. Google's COVID-19 info layer is coming to Maps this week  Android Police
5. Google Maps gets a COVID-19 layer  TechCrunch
6. View Full Coverage on Google News

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September 23, 2020 at 07:25PM FDA Voices on Medical Products

FDA Voices on Medical Products

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September 23, 2020 at 11:08AM Retour sur une épidémie annoncée, avec le nouvel ouvrage Serge Morand

La surprise de la Covid-19 n’en était pas vraiment une pour de nombreux scientifiques qui travaillent sur les maladies émergentes. Serge Morand, dans un nouvel ouvrage paru chez Fayard en septembre 2020, revient sur l’accablement qu’il a ressenti durant les mois qui ont précédé l’épidémie. L’écologue et spécialiste des maladies infectieuses pointe du doigt nos pratiques agricoles et dresse constat pessimiste mais nécessaire des évolutions récentes.

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September 22, 2020 at 10:25AM Pratiques alimentaires et agricoles : une clé pour éviter les épidémies

Connaitre les mécanismes de transmission virale entre humains et chauve-souris est incontournable pour empêcher l’émergence de foyers épidémiques. Des scientifiques ont mobilisé plusieurs disciplines pour étudier la circulation du virus Nipah au Cambodge. Ensemble, épidémiologistes, écologues, virologistes et anthropologues ont analysé la circulation du virus entre chauves-souris et humains, puis identifié les pratiques humaines associées à un risque de contamination. Ces travaux ont fait l’objet d’une publication dans le dernier bulletin de l’Organisation mondiale de la santé.

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September 21, 2020 at 02:34PM Climate change | Drought reduces carbon uptake and crop yields

A series of studies conducted across the European continent, published in September 2020 in Philosophical Transactions B, shows how natural and cultivated areas react to droughts. The findings indicate that in 2018, carbon sinks in Europe diminished by almost 20 %, and crop yields by 40 % in Northern and Eastern Europe. CIRAD plans to develop these approaches in other parts of the world, especially in Africa and South America, to clarify the impacts of extreme weather conditions on food production and food security. The goal is to better anticipate the effects of climate change on agriculture in order to adapt to it.

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September 22, 2020 at 10:25AM Pratiques alimentaires et agricoles : une clé pour éviter les épidémies futures

Connaitre les mécanismes de transmission virale entre humains et chauve-souris est incontournable pour empêcher l’émergence de foyers épidémiques. Des scientifiques ont mobilisé plusieurs disciplines pour étudier la circulation du virus Nipah au Cambodge. Ensemble, épidémiologistes, écologues, virologistes et anthropologues ont analysé la circulation du virus entre chauves-souris et humains, puis identifié les pratiques humaines associées à un risque de contamination. Ces travaux ont fait l’objet d’une publication dans le dernier bulletin de l’Organisation mondiale de la santé.

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September 21, 2020 at 08:19PM FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic | Guidance for Industry, Investigators, and Institutional Review Boards

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September 21, 2020 at 07:52PM 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.

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September 21, 2020 at 06:34PM 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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Thousands of bikers attended rally at Lake of the Ozarks in Missouri - NBC News

1. Thousands of bikers attended rally at Lake of the Ozarks in Missouri  NBC News
2. Missouri biker fest draws tens of thousands to Lake of Ozarks despite 'super spreader' concerns  Fox News
3. Missouri motorcycle rally draws thousands weeks after Sturgis outbreak | TheHill  The Hill
4. Missouri biker festival draws 125,000 to Lake of Ozarks  Daily Mail
5. Drought-hit Mexicans assert demands that water sharing with US ends  Reuters
6. View Full Coverage on Google News

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September 21, 2020 at 02:11PM Investigational COVID-19 Convalescent Plasma

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

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September 21, 2020 at 02:34PM Changement climatique | La sécheresse réduit l’absorption du carbone et le rendement des cultures

Une série d’études menée à l’échelle du continent européen, publiée en septembre 2020 dans Philosophical Transactions B, montre comment les milieux naturels et cultivés réagissent aux sécheresses. Les résultats révèlent qu’en 2018 les puits de carbone en Europe ont baissé de près de 20 %, et le rendement des cultures de 40 % au Nord et à l’Est de l’Europe. Le Cirad va développer ces approches dans d’autres régions du monde, notamment en Afrique et Amérique du Sud, pour préciser les impacts des conditions climatiques extrêmes sur les productions et la sécurité alimentaire. L’objectif est de pouvoir mieux anticiper les effets du changement climatique en agriculture pour s’y adapter.

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September 21, 2020 at 02:22PM Patrick Caron intègre le conseil d’administration du CGIAR

Patrick Caron fait partie des huit membres internationaux nommés au conseil d'administration du CGIAR, système partenarial international de centres de recherche pour le développement. Chercheur au Cirad et ancien directeur général délégué à la recherche et à la stratégie de l’établissement, il est actuellement vice-président de l’Université de Montpellier, directeur de l’Institut d’études avancées de l’I- Site MUSE et président d’Agropolis International.

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September 18, 2020 at 05:24PM Elisabeth Claverie de Saint-Martin: "CIRAD has always believed bringing stakeholders together is the way to achieve sustainable development"

As Elisabeth Claverie de Saint-Martin, CIRAD Director General in charge of Research and Strategy, prepares to participate on 28 September 2020 in the first Rencontres du Développement Durable , she sets out her thoughts on how to achieve sustainable development.

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China T.V. Show Praising Coronavirus Fight Sparks a Backlash from Women - The New York Times

1. China T.V. Show Praising Coronavirus Fight Sparks a Backlash from Women  The New York Times
2. Wuhan Nightclub Packed As Coronavirus Outbreak City Reports No New Cases  LADbible
3. Clubbers cram together and kiss in coronavirus epicentre Wuhan – with zero new cases  Daily Star
4. Nightclubs in Wuhan packed as coronavirus epicentre reports no new cases  Mirror Online
5. View Full Coverage on Google News

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September 18, 2020 at 05:04PM Jobs at the Center for Biologics Evaluation and Research (CBER)

CBER has unique opportunities for individuals with backgrounds in science or administration to fill positions involved in the regulation and research of blood, vaccines and therapeutics.

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September 18, 2020 at 05:24PM Elisabeth Claverie de Saint-Martin : « Le Cirad croit depuis toujours à l’union des acteurs, en faveur du développement durable »

Elisabeth Claverie de Saint-Martin, directrice générale déléguée à la recherche et à la stratégie du Cirad participera aux 1res Rencontres du Développement Durable, lors de la journée du 28 septembre 2020.

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September 17, 2020 at 05:29PM CIRAD launches Cirad’Innov®

CIRAD has launched a new brand, Cirad’Innov®, to promote its work to businesses, professional federations, NGOs, territorial authorities and public agencies, among others. With this brand, the organization hopes to boost the visbility and clarity of its expertise, solutions, appraisals and training courses, to foster partnerships with the socioeconomic players it is keen to work with to ensure sustainable development.

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September 17, 2020 at 05:29PM Le Cirad lance son offre Cirad’Innov®

S’adresser aux entreprises, aux fédérations professionnelles, aux ONG, aux collectivités territoriales et aux agences publiques... telle est la vocation de l’offre qui sera mise en valeur par le Cirad sous la marque Cirad’Innov®. Avec cette offre, l’établissement renforce la visibilité et la clarté de ses compétences, ses solutions, son expertise, ses formations pour favoriser les partenariats avec les acteurs socio-économiques qui souhaitent agir pour le développement durable.

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September 17, 2020 at 04:56PM Roster of the Vaccines and Related Biological Products Advisory Committee

This is the Roster of the Vaccines and Related Biological Products Advisory Committee

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September 16, 2020 at 09:13PM Varivax

Product approval information for Varicella Virus Vaccine Live also known as Varivax.

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September 16, 2020 at 07:14PM Patient Listening Sessions

Patient Listening Sessions led by FDA’s Patient Affairs Staff provide an opportunity for medical product Centers to engage with patients, caregivers, and their advocates about their experience with a disease or condition.

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September 16, 2020 at 05:59PM FDALabel: Full-Text Search of Drug Labeling

FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 100,000 drug labeling documents for FDA-approved drug products, including human and animal prescription and over-the-counter drugs, biological products, and medical devices.

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September 15, 2020 at 10:37PM 6 Tip-offs to Rip-offs: Don't Fall for Health Fraud Scams

Been scammed? Don't be duped into buying fraudulent health products. Learn the tip-offs to rip-offs in this Consumer Update, part of FDA's support of National Consumer Protection Week.

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September 15, 2020 at 10:25PM Cuidado con los "suplementos dietéticos" fraudulentos

Productos fraudulentos pueden causar graves daños e incluso la muerte. La FDA continúa actuando para incrementar la conciencia del consumidor ante la aparición de productos contaminados y peligrosos comercializados como suplementos dietéticos.

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September 15, 2020 at 09:50PM Avoid Dangerous HCG Diet Products

FDA advises consumers to avoid human chorionic gonadotropin (HCG) weight-loss products.

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September 15, 2020 at 08:24PM Coping With Memory Loss

A look at various causes of memory loss and treatment approaches.

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September 15, 2020 at 03:36PM Labeling and Promotion Guidances

This page lists Labeling and Promotion Guidance documents.

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September 15, 2020 at 03:05PM Foreign Regulatory Seminar (Web-Based): CBERs Regulation of Biologics

Foreign Regulatory Seminar (Web-Based): CBERs Regulation of Biologics

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September 15, 2020 at 03:03PM Foreign Regulatory Seminar (Web-Based) - Regulatory Overview

Foreign Regulatory Seminar (Web-Based) - Regulatory Overview

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September 15, 2020 at 03:02PM Foreign Regulatory Seminar (Web-Based) - Office of Blood Research and Review

Office of Blood Research and Review Presentation and Materials for the Foreign Regulatory Seminar (Web-Based)

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September 14, 2020 at 10:55AM The Plant Protection Platform is expanding

Work to extend the Réunion Plant Protection Platform began in August. With almost 3000 m², this will make the experimental facility, run by CIRAD and its partners, one of the organization's largest research infrastructures. The work is due to be completed by 2022.

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September 15, 2020 at 02:58PM Foreign Regulatory Seminar (Web-Based) - Office of Biostatistics and Epidemiology

Office of Biostatistics and Epidemiology presentation and meeting materials for the Foreign Regulatory Seminar (Web-Based)

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September 15, 2020 at 02:56PM Foreign Regulatory Seminar (Web-Based) - Office of Compliance and Biologics Quality

Foreign Regulatory Seminar (Web-Based) - Office of Compliance And Biologics Quality

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September 15, 2020 at 02:53PM Foreign Regulatory Seminar (Web-Based) - Office of Tissues and Advanced Therapies

Foreign Regulatory Seminar (Web-Based) - Office of Tissues and Advanced Therapies

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September 15, 2020 at 02:51PM Foreign Regulatory Seminar (Web-Based) - Office of Vaccines Research and Review

Foreign Regulatory Seminar (Web-Based) - Office of Vaccines Research and Review

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September 15, 2020 at 02:48PM Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry

Geriatric Information in Human Prescription Drug and Biological Product Labeling

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September 14, 2020 at 10:06PM Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment

Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment

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AstraZeneca Shows the Risk of Investing in Coronavirus Vaccine Stocks - Motley Fool

1. AstraZeneca Shows the Risk of Investing in Coronavirus Vaccine Stocks  Motley Fool
2. Vaccine Makers Keep Safety Details Quiet, Alarming Scientists  The New York Times
3. COVID-19 outbreaks at colleges worry experts as some students continue to ignore health rules  CBS This Morning
4. Scientists relieved as coronavirus vaccine trial restarts — but question lack of transparency  Nature.com
5. Valneva signs $1.6B supply, development agreement with UK for coronavirus vaccine hopeful  FiercePharma
6. View Full Coverage on Google News

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September 14, 2020 at 06:30PM Considerations for the Use of Real-World Evidence to Assess the Effectiveness of Preventive Vaccines - 09/17/2020 - 09/18/2020

The purpose of this online symposium is to exchange information with stakeholders from industry, academia, and government about the scientific, clinical, and regulatory challenges and opportunities in using RWE to assess the effectiveness of preventive vaccines.

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September 10, 2020 at 01:48AM Coronavirus (COVID-19) | CBER-Regulated Biologics

This page and the associated links provide information on guidance and advice relevant to the development of therapies to treat or prevent COVID-19, and contact information for developers seeking additional information or assistance.

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September 10, 2020 at 01:48AM Coronavirus (COVID-19) | CBER-Regulated Biologics

This page and the associated links provide information on guidance and advice relevant to the development of therapies to treat or prevent COVID-19, and contact information for developers seeking additional information or assistance.

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September 14, 2020 at 10:55AM Le Pôle de Protection des Plantes prend de l’envergure

Les travaux d’extension du Pôle de protection des plantes à la Réunion ont démarré en août. Avec près de 3000 m², cet espace d’expérimentation scientifique, porté par le Cirad et ses partenaires, va devenir une des plus grandes infrastructures de recherche de l’établissement. Fin de chantier prévu pour 2022.

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Gaza Strip struggles to cope as coronavirus outbreak takes its toll - NBC News

1. Gaza Strip struggles to cope as coronavirus outbreak takes its toll  NBC News
2. Raising kids in Gaza was hard enough. Then came a lockdown within the lockdown.  The Washington Post
3. To avoid spreading the coronavirus, stop talking so much, be quiet - Business Insider  Business Insider
4. When will the world stop ignoring what is happening in Gaza?  Al Jazeera English
5. View Full Coverage on Google News

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Michigan State University students asked to self-quarantine after Covid-19 outbreak - CNN

1. Michigan State University students asked to self-quarantine after Covid-19 outbreak  CNN
2. All Michigan State students asked to quarantine due to 'exponential growth' of COVID-19  ABC News
3. Michigan State University Renames Building That Bears Name of Alleged Ku Klux Klan Member  Newsweek
4. Some college towns grapple with Covid-19 after students return for fall semester  CNN
5. U.S. Coronavirus-Case Count Is Highest in a Week  The Wall Street Journal
6. View Full Coverage on Google News

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France to Smooth Snarled Testing Process as Virus Pressure Grows - The New York Times

1. France to Smooth Snarled Testing Process as Virus Pressure Grows  The New York Times
2. France’s Hospitalizations Rise as Virus Spread ‘Won’t Stop’  Bloomberg
3. French PM to end self-isolation after another negative COVID-19 test  Reuters
4. France Witnessing "Clear Worsening" Of COVID-19 Outbreak: PM  NDTV
5. France Daily Coronavirus Cases Top 10000, Most Since Lockdown  Bloomberg
6. View Full Coverage on Google News

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September 11, 2020 at 09:06PM FDA Patient Engagement Opportunities

A description of some the opportunities for patients, caregivers and advocates to engage wit the FDA.

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A group of students knew they had covid-19. They hosted a party over Labor Day anyway. - The Washington Post

1. A group of students knew they had covid-19. They hosted a party over Labor Day anyway.  The Washington Post
2. Fraternities blamed for campus coronavirus outbreaks as universities struggle to keep students in class  CNBC
3. Coronavirus US: Ohio student who tested positive has house party  Daily Mail
4. University of Alabama suspends 33 students; 639 face discipline  Atlanta Journal Constitution
5. SUNY Albany reports 'very concerning' COVID-19 outbreak  New York Post
6. View Full Coverage on Google News

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September 11, 2020 at 07:24PM Safely Using Hand Sanitizer

You can help stop the spread of COVID-19 disease by washing your hands with soap and water for 20 seconds every time. If soap and water are not available, alcohol-based hand sanitizers can be used if they contain at least 60% alcohol and are used properly.

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September 11, 2020 at 05:59PM Developing a Toolkit to Assess Efficacy of Ebola Vaccines and Therapeutics

MCMi regulatory science project to research issues that are key to understanding and predicting if—and how—vaccines and therapeutics to prevent and treat Ebola will show efficacy

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September 11, 2020 at 05:32PM FDA Voices

Insights into the agency's work in the areas of medical products, food, tobacco, policy, consumer safety and enforcement.

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September 11, 2020 at 04:47PM FDA Patient Engagement Partnerships

FDA Patient Engagement Partnerships

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September 11, 2020 at 04:44PM FDA Patient Engagement Overview*

FDA Patient Engagement Overview

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September 11, 2020 at 04:43PM The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health

FDA is committed to making decisions regarding the authorization or approval of COVID-19 vaccines that are guided by science and data.

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September 11, 2020 at 04:36PM Learn About FDA Patient Engagement

Learn about the different ways that patients and caregivers are working with the FDA to have their voice included in medical product approvals and FDA policy.

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September 10, 2020 at 06:32PM TerrAmaz: a new partnership to reconcile the fight against deforestation with development in the Amazon

The TerrAmaz project will serve to support Amazonian communities, starting with five pilot territories in Brazil, Colombia, Ecuador and Peru, in the fight against deforestation and the transition to sustainable development pathways. The project, coordinated by CIRAD, in partnership with ONF-International and AVSF, with 9.5 million euros of financial support from AFD over four years, was launched on 10 September. TerrAmaz fits in with France's commitment to an International Alliance for the Preservation of Forests and the national strategy against imported deforestation (SNDI).

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September 10, 2020 at 06:32PM TerrAmaz: a new partnership to reconcile the fight against deforestation with development in Amazonia

The TerrAmaz project will serve to support Amazonian communities, starting with five pilot territories in Brazil, Colombia, Ecuador and Peru, in the fight against deforestation and the transition to sustainable development pathways. The project, coordinated by CIRAD, in partnership with ONF-International and AVSF, with 9.5 million euros of financial support from AFD over four years, was launched on 10 September. TerrAmaz fits in with France's commitment to an International Alliance for the Preservation of Forests and the national strategy against imported deforestation (SNDI).

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September 10, 2020 at 01:14AM La función fundamental de la FDA para garantizar el suministro de vacunas contra la influenza

Suministro de vacunas contra la influenza

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September 10, 2020 at 01:14AM ¿Qué es la terapia genética? ¿Cómo funciona?

La terapia genética es el proceso de substituir genes defectuosos por genes sanos, agregar genes nuevos para ayudar al cuerpo a combatir o a tratar enfermedades, o desactivar genes problemáticos. Promete transformar la medicina y generar opciones para los pacientes que viven con enfermedades difíciles e incluso incurables. Conozca cómo funciona esta innovadora terapia.

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September 10, 2020 at 01:14AM ¿Qué personas participan en los ensayos clínicos?

La FDA está haciendo la información demográfica de los ensayos clínicos, tal como la inclusión de mujeres y grupos minoritarios, más transparente y más fácilmente disponible para los consumidores.

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September 10, 2020 at 01:13AM Temporada de huracanes: Prepárese

Con el inicio de la temporada de huracanes, siga estas sugerencias útiles para estar preparado cuando comiencen las inundaciones.

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September 10, 2020 at 01:13AM La FDA acelera la innovación en la creación de terapias para las enfermedades raras

La Oficina del Desarrollo de Productos Huérfanos de la Administración de Alimentos y Medicamentos pone recursos educativos de internet a disposición de la industria y de los pacientes sobre el tema de las enfermedades raras. La página se inaugura el Día Internacional de las Enfermedades Raras, el 28 de febrero; los temas incluyen cómo interactuar con la FDA.

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September 10, 2020 at 01:13AM La FDA actúa para prevenir más casos de escasez de medicamentos

Un nuevo plan estratégico y la propuesta de una nueva regla aspiran a prevenir la escasez de medicamentos y productos biológicos cruciales.

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White House says reducing record debt will be 'big second-term priority' for Trump | TheHill - The Hill

1. White House says reducing record debt will be 'big second-term priority' for Trump | TheHill  The Hill
2. Trump told Woodward he downplayed COVID-19 to prevent mass panic, McEnany says  New York Post
3. Trump admitted to Woodward he downplayed coronavirus threat in early days of outbreak  CBS News
4. Former spy chief Dan Coats had 'deep suspicions' that Putin 'had something' on Trump: Woodward book  Washington Examiner
5. View Full Coverage on Google News

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September 10, 2020 at 01:14AM El relanzamiento de la etiqueta de información nutricional: Historia de dos etiquetas

La etiqueta de información nutricional del empaque que los consumidores ven a la hora de comprar comestibles o preparar una comida ha recibido un cambio de imagen.

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September 10, 2020 at 01:14AM Comer o no comer: Los productos decorativos en los alimentos pueden no ser seguros

La FDA sabe que algunas brillantinas y colorantes en polvo decorativos no comestibles son promocionados para su uso en alimentos, pero los consumidores deben saber que, de hecho, estos productos pueden contener materiales que no deben ingerirse. He aquí cómo saber si dichos materiales son o no comes

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September 10, 2020 at 01:14AM Alivie el dolor de la dentición y las necesidades sensoriales de los bebés y los niños mayores de una manera segura

La dentición es una fase normal de la infancia que no necesita “curarse” con medicamentos recetados o de venta libre. La FDA advierte a los padres que los productos que contienen benzocaína no son seguros para tratar la dentición en los niños. Hay alternativas no tóxicas más seguras.

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September 10, 2020 at 01:14AM Al grano: ¿cuánta cafeína es demasiada?

¿En qué alimentos se encuentra la cafeína? ¿Puede la cafeína representar un peligro para su salud? Si quiere reducir su consumo de cafeína, ¿cómo puede hacerlo de una manera saludable? Este artículo para el consumidor responde a estas y otras preguntas clave sobre la cafeína.

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September 10, 2020 at 01:14AM Tenga cuidado con las falsas promesas de las supuestas curas para el Alzheimer

Tenga cuidado con las falsas promesas de las supuestas curas para el Alzheimer

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September 10, 2020 at 01:14AM La función fundamental de la FDA para garantizar el suministro de vacunas contra la influenza

Suministro de vacunas contra la influenza

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September 10, 2020 at 01:14AM Verdad o Mito: lo que debe saber sobre cómo dejar de fumar y los medicamentos de ayuda

Casi el 70 por ciento de los fumadores actuales afirman que desean dejar de fumar, pero conseguirlo puede ser difícil y a menudo requiere múltiples intentos.

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September 10, 2020 at 01:14AM Tenga cuidado con las falsas promesas de las supuestas curas para el Alzheimer

Tenga cuidado con las afirmaciones falsas sobre los tratamientos para el Alzheimer.

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September 10, 2020 at 01:14AM Do You Vape? See These Tips on How to Keep E-Liquids Away from Children

Accidentally touching or drinking e-liquids can be dangerous and even deadly for young children. So it’s important to handle and store these products carefully, to teach children to stay away from these products, and to be prepared for emergencies. Consider these tips.

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September 10, 2020 at 01:14AM Cuatro consejos para dejar de fumar

¿Quiere dejar de fumar este año? Casi 70 por ciento de los fumadores adultos dice que quiere dejar de fumar. Siga estos consejos y conozca los recursos y productos aprobados por la FDA.

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September 10, 2020 at 01:14AM La FDA advierte contra el uso de silicona inyectable para delinear y mejorar la figura

Los rellenos dérmicos inyectables son dispositivos médicos controlados por la Administración de Alimentos y Medicamentos de los Estados Unidos, pero ninguno está aprobado por la dependencia para delinear o mejorar la figura con cantidades grandes. Entérese de por qué la silicona inyectable y otros productos no sancionados (también llamados rellenos de glúteos, rellenos de senos o productos para rellenar los espacios entre los músculos) son peligrosos y deben evitarse.

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September 10, 2020 at 01:13AM Últimas noticias en investigación: Los científicos de la FDA estudian la función cerebral pediátrica

En el Centro Nacional de Investigaciones Toxicológicas de la FDA, los investigadores estudian la función cerebral pediátrica, para lo cual han creado una herramienta innovadora.

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September 10, 2020 at 01:13AM Una década de progreso en el tratamiento del cáncer de próstata

Tras una década de progreso, la FDA aún mantiene informado al público sobre las terapias para el cáncer de próstata.

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September 10, 2020 at 01:13AM Lo que usted necesita saber sobre las mamografías

Las mamografías siguen siendo la mejor herramienta para la detección del cáncer de seno. Conozca cómo la FDA certifica a los centros que realizan mamografías —y aprueba y autoriza los dispositivos para realizarlas— a fin de mantenerla a usted sana y salva.

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September 10, 2020 at 01:13AM Las investigaciones de la FDA ayudan a mantener sanos a los animales... y a las personas

Además de apoyar la evaluación de nuevos medicamentos veterinarios, el trabajo que hace la FDA con los animales ayuda a proteger el abasto de alimentos en los Estados Unidos para mantener sana a la gente.

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September 10, 2020 at 01:13AM Avances para salvar vidas con sangre

Un oficial de la Oficina de Investigación y Revisión Hematológica de la FDA discute alentadoras tecnologías que incluyen el uso de sangre y productos sanguíneos, para extender la vida de los productos sanguíneos mediante el uso de la tecnología del DNA hasta una mejor combinación entre donantes y receptores.

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September 09, 2020 at 10:49PM FDA's Food and Cosmetics Information Center Answers Your Questions

FDA's Food and Cosmetic Information Center (FCIC) answers questions about nutrition and the safety and labeling of food, dietary supplements and cosmetics. Since the pandemic began, the FCIC has answered an unusually high volume of inquiries, many relating to food and cosmetic safety and COVID-19.

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250,000 COVID-19 infections from Sturgis? 'Made up' numbers, S.D. governor says - NBC News

1. 250,000 COVID-19 infections from Sturgis? 'Made up' numbers, S.D. governor says  NBC News
2. Study says Sturgis motorcycle rally was a 'super-spreader' | USA TODAY  USA TODAY
3. Sturgis Motorcycle Rally was 'superspreading event' that cost public health $12.2 billion: analysis | TheHill  The Hill
4. Coronavirus: Almost 20% of cases in past month stem from controversial motorcycle rally, research claims  The Independent
5. Video: SD governor dismisses Sturgis COVID outbreak as 'napkin math' - Business Insider  Business Insider
6. View Full Coverage on Google News

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September 09, 2020 at 09:31PM Adding Folic Acid to Corn Masa Flour May Prevent Birth Defects

When consumed by women before and during pregnancy, folic acid, a B vitamin, may help prevent neural tube defects (NTDs).

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September 09, 2020 at 06:09PM Cold Facts to Help Avoid Injury from Water-Circulating Hot/Cold Therapy Devices

When not used properly, devices that circulate water to provide hot or cold therapy can pose a risk of injury, especially cold-induced injuries.

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September 09, 2020 at 03:33PM La FDA se compromete a proteger la salud de los niños al ayudar a reducir su exposición a la radiación de rayos X

La FDA se compromete a proteger la salud de los niños al ayudar a reducir su exposición a la radiación de rayos X.

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September 09, 2020 at 03:33PM Adult Stem Cell Research Shows Promise

FDA scientists are working on an unprecedented project. They are studying adult mesenchymal stem cells (MSCs), which are cells that can turn into a variety of cell types and tissues including those that form fat, cartilage and bone. MSC-based products have the potential to be used for cellular repair, restoration, replacement and regeneration if approved by FDA.

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September 09, 2020 at 03:33PM Mezclar medicamentos y suplementos alimenticios puede poner en peligro su salud

¿Es buena idea mezclar medicamentos y suplementos alimenticios? Entérese cómo tomarlos juntos puede poner en peligro su salud y por qué es importante hablarlo con su profesional de la salud.

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September 09, 2020 at 03:33PM No se deje engañar por estafas del fraude de la salud

FDA has created a new website to help consumers protect themselves

from fraudulent health products and schemes

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September 09, 2020 at 03:33PM La FDA insta a ampliar la participación y la diversidad en los ensayos clínicos

La FDA insta a que más personas -- incluyendo de la tercera edad, mujeres, y miembros de diversos grupos étnicos y raciales -- participen en ensayos clínicos. Entérese de por qué.

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September 09, 2020 at 03:33PM Las campañas de la FDA para la prevención del tabaquismo llegan hasta donde “viven” los adolescentes

La FDA emprende campañas de educación pública innovadoras para informar a los jóvenes sobre los peligros del tabaquismo.

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September 09, 2020 at 03:33PM 5 Tips for Traveling to the U.S. With Medications

Can you bring foreign drugs into the U.S.? Or refill a foreign prescription at a U.S. pharmacy? The U.S. Food and Drug Administration can help you understand the rules for flying with medications or shipping them from overseas.

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September 09, 2020 at 03:33PM You Can Help Cut Acrylamide in Your Diet

Scientists believe that acrylamide--a chemical that can form in some foods--may cause cancer in humans. Learn more about acrylamide and steps you can take to cut down on the amount that you and your family consume.

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September 09, 2020 at 03:33PM Why You Should Care About Regulatory Science

Regulatory science isn't a sexy title but this field has a big impact on your daily life. It's how FDA learns whether the products you use are safe and effective.

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September 09, 2020 at 03:33PM Don't Get Burned: Stay Away From Ear Candles

The Food and Drug Administration is warning consumers to steer clear of devices being marketed as ear candles, which the agency says pose serious risks, including burns.

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September 09, 2020 at 03:33PM Perro bueno, alimento malo: alimentos para las personas que son malos para su perro

Algunos alimentos destinados para consumo de las personas pueden ser peligrosos, e incluso mortales, para su perro

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September 09, 2020 at 03:33PM Proteja a sus perros y gatos de los peligros de las fiestas decembrinas

Los peligros para las mascotas abundan durante las celebraciones decembrinas. Proteja a su perro esta temporada de fiestas

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September 09, 2020 at 03:33PM Productos inyectables para aclarar la piel: lo que debe saber

Los productos inyectables para aclarar la piel son medicamentos que no han sido aprobados ni evaluados y que podrían causar posibles daños, según advierte la Administración de Medicamentos y Alimentos (FDA). La FDA no ha aprobado ningún medicamento inyectable para blanquear o aclarar la piel.

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September 09, 2020 at 03:33PM Mantenga los lirios o azucenas fuera del alcance de sus gatos

Muchas personas tienen azucenas blancas en su casa en esta época del año, pero esto podría ser peligroso si tienen un gato. La FDA advierte que los gatos pueden sufrir graves daños renales e incluso morir si comen aunque sea un pedacito de un lirio o azucena.

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September 09, 2020 at 03:33PM Mejorando la seguridad de los dispositivos médicos en casa

Hoy en día, muchos dispositivos médicos se usan en el hogar y permiten a las personas que tienen condiciones médicas llevar una vida plena y activa. No obstante, los usuarios se enfrentan a muchos retos. La FDA está trabajando para hacer que el uso de estos dispositivos sea más seguro y para ayudar a los consumidores a obtener acceso a instrucciones más claras.

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September 09, 2020 at 03:33PM Adult Stem Cell Research Shows Promise

FDA scientists are working on an unprecedented project. They are studying adult mesenchymal stem cells (MSCs), which are cells that can turn into a variety of cell types and tissues including those that form fat, cartilage and bone. MSC-based products have the potential to be used for cellular repair, restoration, replacement and regeneration if approved by FDA.

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September 09, 2020 at 03:33PM La FDA insta a ampliar la participación y la diversidad en los ensayos clínicos

La FDA insta a que más personas -- incluyendo de la tercera edad, mujeres, y miembros de diversos grupos étnicos y raciales -- participen en ensayos clínicos. Entérese de por qué.

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Debates over race, history and values roil Texas A&M as campus diversifies - The Washington Post

1. Debates over race, history and values roil Texas A&M as campus diversifies  The Washington Post
2. West Virginia University suspends in-person classes amid COVID-19 surge  New York Post
3. West Virginia University becomes the latest school to backtrack on in-person classes after a spike in Covid-19 cases  CNN
4. COVID -19: A course on going to college safely | TheHill  The Hill
5. ‘Reckless’ And ‘Reprehensible’ Frat Party Linked To Coronavirus Outbreak At UNH: Here Are The Latest College Coronavirus Updates  Forbes
6. View Full Coverage on Google News

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