The Year Of Pandemic: COVID-19 By The Numbers : Goats and Soda - NPR

1. The Year Of Pandemic: COVID-19 By The Numbers : Goats and Soda  NPR
2. Inside Wuhan One Year After Covid Outbreak | NBC News NOW  NBC News
3. One year after COVID first appeared in Wuhan, China, US approaches 20 million cases, Massachusetts surpasses  MassLive.com
4. Wuhan a year after Covid struck: 'Everyone wants to reset 2020'  The Guardian
5. China Is Making It Harder to Solve the Mystery of How Covid Began  Bloomberg
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December 31, 2020 at 09:17PM CBER Secure Email Policy Takes Effect October 1, 2018

CBER Secure Email Policy Takes Effect October 1, 2018

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December 31, 2020 at 08:44PM 2018 Center for Biologics Evaluation and Research Science Symposium - 06/25/2018 - 06/26/2018

The purpose of the public symposium is to discuss scientific topics related to the regulation of biologics and highlight science conducted at CBER by showcasing how scientific research informs regulatory decision making and to provide a forum for developing collaborations within FDA and with external organizations.

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December 31, 2020 at 08:13PM 21st US-Japan Cellular and Gene Therapy Conference - 03/01/2018 - 03/01/2018

The goal of the annual US-Japan cellular and gene therapy conference is to exchange ideas on cutting edge and diverse areas of biomedical research, and enhance opportunities for collaborations among scientists from the US and Japan.

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December 31, 2020 at 08:06PM 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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December 31, 2020 at 04:38PM 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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December 31, 2020 at 03:39PM FDA Voices on Policy

FDA Voices on Policy

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China Is Making It Harder to Solve the Mystery of How Covid Began - Bloomberg

1. China Is Making It Harder to Solve the Mystery of How Covid Began  Bloomberg
2. A year since Covid emerged, Americans in Wuhan are afraid again — for the U.S.  Yahoo News
3. Inside Wuhan One Year After Covid Outbreak | NBC News NOW  NBC News
4. Covid-19 Pandemic: Live Updates and News for Dec. 31, 2020  Bloomberg
5. China clamping down on research into origins of COVID-19 pandemic  Fox News
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December 30, 2020 at 08:56PM 2020 at FDA: A Year of Unparalleled Contributions to Public Health

2020 has been a year like no other in recent memory for public health and FDA.

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December 30, 2020 at 06:06PM Developing and Manufacturing Drugs Including Biologics

This material is intended to be a helpful resource that consolidates information relevant for drug manufacturers making products for the U.S. market. It is not a comprehensive list of all applicable statutory and regulatory requirements.

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Lori Loughlin had emotional reunion with daughters Olivia Jade and Isabella after released from prison - Fox News

1. Lori Loughlin had emotional reunion with daughters Olivia Jade and Isabella after released from prison  Fox News
2. Janet Hubert slams Lori Loughlin prison release: ‘to be white, blonde and privileged’  Yahoo News
3. Olivia Jade's Mom Lori Loughlin Gets Released From Prison  Inside Edition
4. Monday Morning Headlines: Lori Loughlin Leaves Prison Where Outbreak Is Ongoing  SFist
5. Lori Loughlin Had "Bittersweet" Reunion with Daughters After Spending Final 2 Weeks of Sentence in Isolation  Yahoo Lifestyle
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Lori Loughlin had emotional reunion with daughters Olivia Jade and Isabella after released from prison - Fox News

1. Lori Loughlin had emotional reunion with daughters Olivia Jade and Isabella after released from prison  Fox News
2. Lori Loughlin released from prison after completing sentence for college admissions scandal  Yahoo Entertainment
3. Olivia Jade's Mom Lori Loughlin Gets Released From Prison  Inside Edition
4. Monday Morning Headlines: Lori Loughlin Leaves Prison Where Outbreak Is Ongoing  SFist
5. Lori Loughlin Had "Bittersweet" Reunion with Daughters After Spending Final 2 Weeks of Sentence in Isolation  Yahoo Lifestyle
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December 29, 2020 at 05:42PM Application Submissions Guidances

This page lists Application Submissions Guidance documents.

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December 28, 2020 at 08:15PM Adacel

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed

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Nearly half a million people may have had Covid-19 in Wuhan, study shows. That's almost 10 times the official figure - CNN

1. Nearly half a million people may have had Covid-19 in Wuhan, study shows. That's almost 10 times the official figure  CNN
2. ‘This Means a Lot.' After Their City Was Battered by Coronavirus, Wuhan's Soccer Fans Find Redemption  TIME
3. Wuhan’s Covid Cases May Have Been 10 Times Higher, Study Shows  Bloomberg
4. What is China trying to hide about the coronavirus?  The Washington Post
5. Chinese journalist who documented Wuhan coronavirus outbreak jailed for 4 years  CNN
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Lori Loughlin Finishes Prison Sentence Following College Admissions Scandal | NBC News NOW - NBC News

1. Lori Loughlin Finishes Prison Sentence Following College Admissions Scandal | NBC News NOW  NBC News
2. Lori Loughlin released from prison after completing sentence for college admissions scandal  Yahoo Entertainment
3. Lori Loughlin released from prison after 2-month sentence for college admissions scam  CNN
4. Monday Morning Headlines: Lori Loughlin Leaves Prison Where Outbreak Is Ongoing  SFist
5. Actress Lori Loughlin Released From Federal Prison | MSNBC  MSNBC
6. View Full Coverage on Google News

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December 28, 2020 at 11:43PM Coronavirus (COVID-19) Update: December 28, 2020

Coronavirus (COVID-19) Update

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Wuhan citizen journalist jailed for four years in China's Christmas crackdown - The Guardian

1. Wuhan citizen journalist jailed for four years in China's Christmas crackdown  The Guardian
2. Chinese journalist who documented Wuhan coronavirus outbreak jailed for 4 years  CNN
3. China Jails Ex-Lawyer for Four Years Over Virus Reports in Wuhan  Bloomberg
4. 2020 Recap: How COVID-19 has changed everything we do  WWLP.com
5. She Chronicled China’s Crisis. Now She Is Accused of Spreading Lies.  The New York Times
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Giants lose to Ravens with playoff hopes on life support - New York Post

1. Giants lose to Ravens with playoff hopes on life support  New York Post
2. Source -- Baltimore Ravens fined $250K by NFL for COVID-19 outbreak  ESPN
3. Mike Preston’s report card: Position-by-position grades for Ravens’ 27-13 win over Giants | COMMENTARY  Baltimore Sun
4. Ravens Arrive at M&T Bank Stadium Week 16 vs. Giants | Baltimore Ravens  Baltimore Ravens
5. Gus Edwards Keeps Ravens Going w/ 15 Carries | NFL 2020 Highlights  NFL
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Virus Outbreak: News and Analysis From Dec. 26, 2020 - Bloomberg

Virus Outbreak: News and Analysis From Dec. 26, 2020  BloombergView Full Coverage on Google News

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Colorado In-N-Out Burgers linked to 80 coronavirus cases, 25 infections ‘probable,’ health agency says - Fox News

1. Colorado In-N-Out Burgers linked to 80 coronavirus cases, 25 infections ‘probable,’ health agency says  Fox News
2. In-N-Out Outbreak: 80 Employees Test Positive At Colorado Locations  CBS Denver
3. COVID-19 Outbreak at 2 Colorado In-N-Outs, 80 Positive Tests  TMZ
4. Colorado’s two In-N-Out locations declared COVID-19 outbreaks as 80 employees test positive  The Denver Post
5. 80 Workers at Two In-N-Out Restaurants Test Positive for COVID-19 One Month After Opening  Newsweek
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Oregon Governor wants teachers to have access to vaccine before other essential workers - KATU

1. Oregon Governor wants teachers to have access to vaccine before other essential workers  KATU
2. A person who went to work while sick is likely the cause of two separate Covid-19 outbreaks in Oregon  CNN
3. Oregon Health Authority reports 871 new COVID-19 cases, 12 additional deaths  KPTV.com
4. Drug overdose deaths spike in Oregon, U.S.; CDC says ‘disruption’ from pandemic contributed to dramatic incre  OregonLive
5. 7 dead in 2 Oregon coronavirus outbreaks linked to single case  New York Daily News
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President Trump and first lady wish Americans a Merry Christmas - Fox News

1. President Trump and first lady wish Americans a Merry Christmas  Fox News
2. Trump seen golfing after vowing to 'work tirelessly' amid crises  CNN
3. Sidney Powell Wants to Fight for Donald Trump—But His Aides Won't Let Her, She Says  Newsweek
4. Trump heads to Mar-a-Lago for Christmas with government funding, coronavirus relief package in limbo  Fox News
5. Christmas Eve travel: Millions on the move in US despite COVID-19 outbreak  WLS-TV
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What Killed St. Joseph's Residents: COVID-19 Or A Decision To Evacuate Them? - NPR

1. What Killed St. Joseph's Residents: COVID-19 Or A Decision To Evacuate Them?  NPR
2. Point Pleasant, NJ Coronavirus Updates & News For December 24  Patch.com
3. 'When am I considered immune after receiving the vaccine?' Dr. Murphy answers viewer COVID-19 questi  WGN News
4. New Jersey EMTs In Early Epicenter Of Coronavirus Outbreak Brace For Surge  NPR
5. COVID-19, recreational marijuana top New Jersey’s stories  The Philadelphia Inquirer
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Oregon officials say person went to work with COVID-19 symptoms and sparked two outbreaks | TheHill - The Hill

1. Oregon officials say person went to work with COVID-19 symptoms and sparked two outbreaks | TheHill  The Hill
2. L.A. County’s COVID-19 hospitalization spike is now off the charts  KTLA Los Angeles
3. Franklin County adds 129 COVID-19 cases as mask mandate not renewed in the county  FOX 2 St. Louis
4. Dallas County adds 30 COVID-19 deaths, 2,366 new cases; the county’s death toll is now over 1,500  The Dallas Morning News
5. COVID-19 in NC: Hospitalizations increase again to new record, daily cases hit 5,600  CBS17.com
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Covid-19 is now on every continent as Antarctica records its first outbreak - CNN

1. Covid-19 is now on every continent as Antarctica records its first outbreak  CNN
2. COVID-19 has reached Antarctica, infecting 36 at research base  New York Post
3. Pandemic reaches Antarctica, last untouched continent  Washington Post
4. COVID-19 Strikes Antarctica, Its 7th Continent, As Chilean Base Hit With Virus  Newsweek
5. Antarctica reports first coronavirus cases  Axios
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December 23, 2020 at 12:08AM Coronavirus (COVID-19) Update: December 22, 2020

Coronavirus (COVID-19) Update

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December 22, 2020 at 09:08PM Strong Fertility Center - 593262 - 12/11/2020

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

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December 22, 2020 at 09:06PM Strong Fertility Center - 593262 - 10/29/2019

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

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December 22, 2020 at 09:05PM Pandemic Influenza Information

Pandemic influenza (flu) is a significant global public health threat. Preparedness has been recognized as a critical local, national and worldwide priority

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December 22, 2020 at 08:25PM Smallpox

Smallpox is a serious, highly contagious, and sometimes fatal infectious disease. There is no specific treatment for smallpox disease, and the only prevention is vaccination. The name is derived from the Latin word for "spotted" and refers to the raised bumps that appear on the face and body of an infected person.

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December 22, 2020 at 07:59PM Anthrax

Anthrax is an infectious disease caused by spores of the bacterium, Bacillus anthracis. CBER continues to work with multiple manufacturers in the development of immune globulins as a potential treatment for anthrax infection.

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December 22, 2020 at 06:45PM Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices - Questions and Answers (Revised)

FDA is issuing this guidance to provide clarity on meetings and user fees during the COVID-19 public health emergency.

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Thai Travel Industry Faces ‘Nail in Coffin’ After New Outbreak - Bloomberg

1. Thai Travel Industry Faces ‘Nail in Coffin’ After New Outbreak  Bloomberg
2. Thai PM urges calm as new coronavirus outbreak sees cases surge  Yahoo News
3. Thailand had kept its coronavirus cases under control. Now it's testing thousands as it battles a shrimp market outbreak  CNN
4. Thai Virus Cases Climb As Stricter Border Surveillance Ordered  Bloomberg
5. Covid-19: Thailand tests thousands after virus outbreak in seafood market  BBC News
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December 22, 2020 at 12:25AM Coronavirus (COVID-19) Update: December 21, 2020

Coronavirus (COVID-19) Update

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December 21, 2020 at 07:53PM Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry

Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry

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December 21, 2020 at 06:28PM Recommendations for the Use of Vaccines Manufactured with Bovine-Derived Materials

Recommendations for the Use of Vaccines Manufactured with Bovine-Derived Materials

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December 21, 2020 at 04:38PM Vaccine Safety Questions and Answers

Questions and answers on vaccine safety.

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December 21, 2020 at 04:08PM Influenza Virus Vaccine Safety & Availability

Influenza (flu) is a contagious respiratory disease that is caused by influenza viruses. Influenza viruses infect the respiratory tract (nose, throat, and lungs) in humans.

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Virus Outbreak: News and Analysis From Dec. 21 - Bloomberg

1. Virus Outbreak: News and Analysis From Dec. 21  Bloomberg
2. More Countries Impose U.K. Travel Restrictions Amid Concern Over Virus Mutation  The New York Times
3. Concerns rise over COVID-19 mutation in UK  WGN News
4. U.K.'s Hancock Says Virus Mutation Is `Out of Control'  Bloomberg
5. Live updates: Coronavirus relief deal reached; new strain pauses flights out of Britain  The Washington Post
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Trump signs bill extending government funding for 24 hours | TheHill - The Hill

1. Trump signs bill extending government funding for 24 hours | TheHill  The Hill
2. Trump's chief of staff Mark Meadows attempted to hide his COVID-19 diagnosis and the White House outbreak  Yahoo News
3. POLITICO Playbook: It's time to vote - POLITICO  Politico
4. Covid-19 and SolarWinds: America Keeps Paying for Trump's Incompetence  Bloomberg
5. John Kelly is wrong. These were not good people.  The Washington Post
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Thailand had kept its coronavirus cases under control. Now it's testing thousands as it battles a shrimp market outbreak - CNN

1. Thailand had kept its coronavirus cases under control. Now it's testing thousands as it battles a shrimp market outbreak  CNN
2. Thousands line up for tests amid Thailand virus outbreak  ABC News
3. Asia Today: Outbreak grows in Sydney's beach suburbs  The Associated Press
4. Thailand Considers More Lockdowns as Seafood Workers Hit by Virus  Bloomberg
5. Coronavirus live news: Boris Johnson to hold crisis meeting as more countries stop flights from UK  The Guardian
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Thailand had kept its coronavirus cases under control. Now it's testing thousands as it battles a shrimp market outbreak - CNN

Thailand had kept its coronavirus cases under control. Now it's testing thousands as it battles a shrimp market outbreak  CNNView Full Coverage on Google News

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Gov. Bill Lee announces order limiting gatherings as Tennessee’s COVID-19 surge continues - WMC

1. Gov. Bill Lee announces order limiting gatherings as Tennessee’s COVID-19 surge continues  WMC
2. Gov. Bill Lee enacts gathering restrictions, refuses mask mandate as Tennessee COVID-19 outbreak surges  Tennessean
3. Gov. Lee signs executive order to limit social gatherings to 10 people, urges Tennesseans to wear masks  WATE 6 On Your Side
4. “It will completely break our hospitals” Tenn. health commissioner warns of another holiday COVID-19 surge  WVLT
5. TSSAA to release new fan attendance guidelines restricting who can attend indoor high school sports events  Tennessean
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Safe shopping tips as COVID-19 spreads in L.A. area supermarkets - Los Angeles Times

1. Safe shopping tips as COVID-19 spreads in L.A. area supermarkets  Los Angeles Times
2. LA County Health Order To Be Modified To Allow Indoor Services For Places Of Worship -- With Some Ru  CBS Los Angeles
3. L.A. County reports more than 100K new coronavirus cases in just 8 days amid fastest acceleration of infections  KTLA Los Angeles
4. Unprecedented coronavirus outbreaks at L.A. County supermarkets further strains the essential service  KTLA Los Angeles
5. Los Angeles County reverses ban on indoor religious services after Supreme Court decision  KTLA Los Angeles
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Thousands line up for tests amid Thailand virus outbreak - ABC News

1. Thousands line up for tests amid Thailand virus outbreak  ABC News
2. Asia Today: Outbreak grows in Sydney's beach suburbs  The Associated Press
3. Thailand to test thousands after shrimp market COVID outbreak  Yahoo News
4. Thailand Locks Down Coastal Area as Virus Cases Hit Record  Bloomberg
5. Thailand reports 548 new virus cases, highest daily spike  WBOY.com
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Asia Today: Outbreak grows in Sydney's beach suburbs - The Associated Press

Asia Today: Outbreak grows in Sydney's beach suburbs  The Associated Press

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Asia Today: Sydney outbreak grows; Thailand sees big jump - The Associated Press

Asia Today: Sydney outbreak grows; Thailand sees big jump  The Associated PressView Full Coverage on Google News

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Apple just temporarily closed all 53 stores in California and over a dozen in London - The Verge

1. Apple just temporarily closed all 53 stores in California and over a dozen in London  The Verge
2. Apple temporarily closes California stores as virus cases mount  CNBC
3. Apple temporarily shuts all California stores amid COVID-19 outbreak  Reuters
4. Apple to temporarily close all California stores due to COVID-19 case surge  KABC-TV
5. Apple closes California stores amid coronavirus surge  San Francisco Chronicle
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December 19, 2020 at 01:46AM Moderna COVID-19 Vaccine

Information about the Moderna COVID-19 Vaccine

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December 19, 2020 at 01:29AM FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine

Today, the FDA issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The vaccine is for use in individuals 18 years of age and older.

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December 18, 2020 at 10:34PM Vaccine Safety & Availability

Vaccine Safety & Availability

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December 18, 2020 at 05:55PM Vaccine Adverse Events

Information about the Vaccine Adverse Event Reporting System (VAERS), which is a national vaccine safety surveillance program co-sponsored by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) to detect possible signals of adverse events associated with vaccines.

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December 18, 2020 at 07:03PM Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard Therapies - 11/04/2019 - 11/04/2019

The purpose of the public hearing is to obtain public input on the state of the science regarding FMT to treat C. difficile infection not responsive to standard therapies, including the available clinical evidence for safety and effectiveness of FMT for this use and to better understand the impact of FDA’s enforcement policy on product development.

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December 18, 2020 at 02:15PM Consumer Updates

Science-based health and safety information you can trust.

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December 18, 2020 at 02:36AM FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting

FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting

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December 18, 2020 at 12:24AM Coronavirus (COVID-19) Update: December 17, 2020

Coronavirus (COVID-19) Update

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December 17, 2020 at 10:07PM 23rd US-Japan Cellular and Gene Therapy Conference - 03/12/2020 - 03/12/2020

The annual US-Japan Cellular and Gene Therapy Conference will provide scientists from Japan and the U.S. a valuable opportunity to discuss the state of the art of exosome therapies and establish research collaborations.

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December 17, 2020 at 10:01PM 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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December 17, 2020 at 09:07PM Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion

This is the Guidance for industry, Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion. - Updated December 2020

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December 17, 2020 at 07:03PM Section 8400: Marketing Applications

This is the SOPP Section 8400: Marketing Applications main page.

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December 17, 2020 at 02:43PM Vaccines Licensed for Use in the United States

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

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December 17, 2020 at 04:47PM Vaccine EUA Questions and Answers for Stakeholders

Questions and answers about vaccine Emergency Use Authorizations for stakeholders including industry, health care providers, pharmacists, and state, local, tribal, and territorial governments

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December 17, 2020 at 04:01PM Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions

Answers to frequently asked questions about the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19.

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December 17, 2020 at 12:18AM Coronavirus (COVID-19) Update: December 16, 2020

Coronavirus (COVID-19) Update

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December 16, 2020 at 10:31PM Quantitation of AAV-Based Gene Therapy Products - 12/07/2018 - 12/07/2018

The purpose of the public workshop is to discuss best practices when measuring the concentration of AAV vectors and to provide FDA perspective on qualifying such assays. The public workshop will bring together academia, industry, and other stakeholders involved in research, development, and regulation of AAV-Based gene therapy products.

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December 16, 2020 at 09:56PM Developing Predictive Indicators of Genome Stability and Cell Maturation as Measures of Cell Therapy Product Safety and Efficacy

A description of Deborah Hursh's research program and related publications.

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December 15, 2020 at 08:55PM Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products

This the Guidance for Industry, Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products, Level 1, CBER, CDER, Biologics, Drugs, December 2020

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December 15, 2020 at 10:39PM Tissue & Advanced Therapies Research

This page is about Tissue & Advanced Therapies Research

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December 15, 2020 at 06:59PM Guidance Recap Podcast: Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products Podcast

The Guidance Recap Podcast provides highlights for FDA guidance documents straight from the authors.

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December 15, 2020 at 07:58PM Toward More Effective Treatment of Blood Clotting Disorders: Pharmacogenomic Studies of ADAMTS13 and Related Proteins

A description of Chava Kimchi-Sarfaty's research program and related publications.

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December 15, 2020 at 07:07PM Developing Ways to Measure Safety and Efficacy for Tissue-engineered Products

A description of Brenton McCright's research program and related publications.

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December 15, 2020 at 12:34AM Coronavirus (COVID-19) Update: December 14, 2020

Coronavirus (COVID-19) Update

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December 14, 2020 at 10:02PM Questions about Vaccines

Information on general and specific vaccines

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December 14, 2020 at 08:50PM Resources Related to Regenerative Medicine Therapies

Information on FDA’s Framework for the Regulation of Regenerative Medicine Products


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December 14, 2020 at 08:00PM Help Stop the Spread of Coronavirus and Protect Your Family

We can each help slow the spread of coronavirus disease and protect ourselves, our families and our communities. Wash your hands often with soap and water; cover your mouth and nose with a cloth face covering or non-surgical mask when around others; 3) avoid crowds and practice social distancing.

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December 14, 2020 at 02:12PM Measles, Mumps and Rubella Virus Vaccine Live

Product approval information for the Measles, Mumps, and Rubella Virus Vaccine, Live also known as M-M-R II.

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Large COVID outbreak linked to Bay Area basketball program - KRON4

1. Large COVID outbreak linked to Bay Area basketball program  KRON4
2. 3 Santa Clara County hospitals out of ICU beds; 1700 new cases in single day  San José Spotlight
3. COVID-19: Santa Clara County reports outbreak at youth basketball event  The Mercury News
4. Bay Area county launches door-to-door testing amid 'dire' surge  SF Gate
5. COVID Surge: Santa Clara County To Send Teams Door-to-Door To Administer Tests  msnNOW
6. View Full Coverage on Google News

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December 12, 2020 at 03:55AM Pfizer-BioNTech COVID-19 Vaccine

Information about the Pfizer-BioNTech COVID-19 vaccine

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December 12, 2020 at 03:32AM FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine

Today, the FDA issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

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December 11, 2020 at 10:25PM Therapeutic Cloning and Genome Modification

The rapid advances over the past few decades in biotechnologies involving somatic cells and gene therapy offer a great potential in regenerative medicine and for the treatment of genetic defects.

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December 11, 2020 at 12:53PM FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting

FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting

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December 10, 2020 at 11:50PM Coronavirus (COVID-19) Update: December 10, 2020

Coronavirus (COVID-19) Update

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December 10, 2020 at 08:08PM Developing Predictive Indicators of Cell Maturation as Measures of Cell Therapy Product Efficacy and Safety

A description of Deborah Hursh's research program and related publications.

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December 10, 2020 at 03:21PM Coronavirus (COVID-19) Update: FDA Holds Advisory Committee Meeting to Discuss Authorization of COVID-19 Vaccine Candidate as Part of Agency’s Review of Safety and Effectiveness Data

Today, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting to discuss the first request for emergency use authorization for a vaccine for COVID-19 prevention, submitted by Pfizer Inc. in partnership with BioNTech Manufacturing GmbH.

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December 09, 2020 at 11:07PM Cell-specific And Gene-specific Targeting of Gene Therapy Vectors

A description of Jakob Reiser's research program and related publications.

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December 09, 2020 at 09:12PM Approved Cellular and Gene Therapy Products

Listing of licensed and approved products from the Office of Tissues and Advanced Therapies (OTAT).

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December 09, 2020 at 03:12PM Remarks by Dr. Hahn for the Reagan-Udall Foundation's Innovation in Regulatory Science Awards - 12/08/2020

Remarks by Stephen Hahn, MD, Reagan-Udall Foundation for the FDA, Innovation in Regulatory Science Awards, December 8

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December 09, 2020 at 12:20AM Coronavirus (COVID-19) Update: December 8, 2020

Coronavirus (COVID-19) Update

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December 08, 2020 at 10:26PM Testing Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P): Specific Requirements

These are the Specific Requirements for Testing Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P)

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Michigan-Ohio State football game called off due to COVID-19 cases with Wolverines - ESPN

1. Michigan-Ohio State football game called off due to COVID-19 cases with Wolverines  ESPN
2. Ryan Day press conference | Ohio State-Michigan week  WBNS 10TV
3. Ohio State's Rivalry Game Against Michigan Canceled Due to COVID-19 Outbreak at Michigan | Eleven Warriors  Eleven Warriors
4. Michigan resumes limited workouts, with game at Ohio State on Saturday  NBC4 WCMH-TV
5. Finebaum says Ohio State not playing is 'rolling the dice'  247Sports
6. View Full Coverage on Google News

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Michigan football cancels Ohio State game as COVID-19 cases increase - Detroit Free Press

1. Michigan football cancels Ohio State game as COVID-19 cases increase  Detroit Free Press
2. Ohio State's Rivalry Game Against Michigan Canceled Due to COVID-19 Outbreak at Michigan | Eleven Warriors  Eleven Warriors
3. If The Game is canceled, Big Ten can provide backup plans for Buckeyes  Lettermen Row
4. Michigan resumes limited workouts, with game at Ohio State on Saturday  NBC4 WCMH-TV
5. Ryan Day Discusses His Takeaways from Michigan State Game, Preparation for The Game | Eleven Warriors  Eleven Warriors
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Covid-19 hospitalization rates are dropping. That’s terrible news. - Washington Post

1. Covid-19 hospitalization rates are dropping. That’s terrible news.  Washington Post
2. Who Gets Covid-19 Vaccine First? Hospitals Assess How to Divvy Up Shots  The Wall Street Journal
3. Should NJ hospitals be required to tell public about staff COVID-19 outbreaks?  NorthJersey.com
4. Some COVID patients flown out of state as S.D. hospital ICU capacity dwindles  KELOLAND.com
5. Some South Dakotans With COVID Flown Out of State Amid Alarming ICU Shortage  Newsweek
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December 07, 2020 at 08:07PM Remarks by Dr. Hahn to the National Academy of Medicine Town Hall on the COVID-19 Vaccine - 12/04/2020

Remarks by Stephen. Hahn, MD, Commissioner of Food and Drugs, The National Academy of Medicine Town Hall on the COVID-19 Vaccine, Dec. 4, 2020

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December 07, 2020 at 07:23PM 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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December 07, 2020 at 05:15PM Remarks by Dr. Hahn to the FDA-CMS Summit - 12/07/2020

Remarks by Stephen Hahn, MD, Commissioner of Food and Drugs, FDA-CMS Summit, December 7

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‘Now I have nothing’: Tigray conflict has changed Ethiopia for ever, say refugees - The Guardian

1. ‘Now I have nothing’: Tigray conflict has changed Ethiopia for ever, say refugees  The Guardian
2. Ethiopia's conflict stokes humanitarian and virus crisis  Yahoo News
3. Ethiopia’s month-long conflict hampers efforts in fighting one of Africa’s worst COVID-19 outbreaks  KTLA
4. A military victory is cause for cautious optimism in Ethiopia  The Washington Post
5. In Ethiopia, a Nobel Peace laureate goes to war  Los Angeles Times
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December 04, 2020 at 09:32PM 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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December 04, 2020 at 09:27PM Healthcare Providers (Biologics)

Resources for Healthcare Providers on biological products.

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December 04, 2020 at 09:22PM Industry (Biologics)

CBER’s Manufacturers Assistance and Technical Training Branch provides assistance and training to industry, including large and small manufacturers and trade associations, and to respond to requests for information regarding CBER policies and procedures.

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December 04, 2020 at 09:13PM Tissue Guidances

This page contains a listing of tissue related guidances.

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December 04, 2020 at 09:11PM Vaccine and Related Biological Product Guidances

This page contains a listing of vaccine and related biological product guidances

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December 04, 2020 at 07:56PM Remarks by Dr. Hahn to the Remarks to the National Academy of Medicine Town Hall on the COVID-19 Vaccine - 12/04/2020

Remarks by Stephen. Hahn, MD, Commissioner of Food and Drugs, The National Academy of Medicine Town Hall on the COVID-19 Vaccine, Dec. 4, 2020

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December 04, 2020 at 06:05PM 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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John Harbaugh mum on whether Lamar Jackson will return vs. Cowboys - NFL.com

1. John Harbaugh mum on whether Lamar Jackson will return vs. Cowboys  NFL.com
2. Steelers defense on pace for improbable triple crown that no NFL team has ever pulled off in Super Bowl era  CBS Sports
3. Short Week Could Leave Steelers Without Multiple Starters vs. Washington  Sports Illustrated
4. The Ravens game is a huge test for Mike McCarthy and the Cowboys  Blogging The Boys
5. The Unseen Struggle of the Ravens' COVID-19 Outbreak  BaltimoreRavens.com
6. View Full Coverage on Google News

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November 30, 2020 at 04:20PM Why the United States-Mexico-Canada Agreement is Important to FDA

How the many provisions in the United States-Mexico-Canada Agreement affect FDA, advance public health and FDA’s regulatory approaches.

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December 02, 2020 at 12:47AM Requesting FDA Feedback on Combination Products

Final guidance for industry and FDA staff: Requesting FDA Feedback on Combination Products

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December 03, 2020 at 01:42PM Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Announcement - 12/17/2020 - 12/17/2020

This is the CBER Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Announcement.

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Roger Goodell Says NFL Isn't Planning a Bubble Amid COVID-19 Outbreaks - Bleacher Report

1. Roger Goodell Says NFL Isn't Planning a Bubble Amid COVID-19 Outbreaks  Bleacher Report
2. NFL Commissioner Roger Goodell explains COVID decision-making process (FULL INTERVIEW) | NBC Sports  NBC Sports
3. NFL Commissioner Roger Goodell downplays talk of bubble, but 'all options are on the table'  NFL.com
4. NFL playoff bubble? Roger Goodell doesn't see it happening at a neutral site during 2020 postseason  CBS Sports
5. Roger Goodell: NFL won’t reschedule games for competitive considerations  NBC Sports - NFL
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December 02, 2020 at 11:26PM Select CBER Projects and Activities

CBER projects and activities that address the 21st Century Cures Act and the Prescription Drug User Fees Act VI Reauthorization (PDUFA VI) as authorized by the FDA Reauthorization Act (FDARA)

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Nursing homes create 'perfect storm' for Covid outbreaks as cases and deaths surge again - CNBC

1. Nursing homes create 'perfect storm' for Covid outbreaks as cases and deaths surge again  CNBC
2. Nursing homes prepare for the hoidays  WPRI
3. Nursing homes are still getting pummeled by the pandemic  Axios
4. US hits nearly 2,600 Covid-19 deaths in one day -- the highest since April  CNN
5. Nursing-home horrors go way beyond the virus  New York Post
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December 02, 2020 at 04:17PM Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis

This is the Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis; Guidance for Industry.

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December 02, 2020 at 01:08AM Coronavirus (COVID-19) Update: December 1, 2020

Coronavirus (COVID-19) Update

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December 01, 2020 at 02:44PM FDA Voices on Medical Products

FDA Voices on Medical Products

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