Baltimore Ravens-Pittsburgh Steelers game postponed again, to Wednesday, source says - ESPN

1. Baltimore Ravens-Pittsburgh Steelers game postponed again, to Wednesday, source says  ESPN
2. NFL hits new heights of embarrassment as COVID-19 ravages Ravens-Steelers, Broncos' QB situation  Yahoo Sports
3. Report: NFL Cancels Baltimore Ravens Practice Ahead Of Tuesday's Steelers Game  CBS Pittsburgh
4. Source -- NFL mulls third postponement of Baltimore Ravens-Pittsburgh Steelers game amid coronavirus outbreak  ESPN
5. Mark Madden: NFL has billions of reasons to trudge on through covid mess  TribLIVE
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November 30, 2020 at 11:01PM Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate

FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 17, 2020 to discuss Moderna’s emergency use authorization request for a COVID-19 vaccine.

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November 30, 2020 at 08:46PM Patient Engagement Collaborative

The Patient Engagement Collaborative (PEC) is an advancement in FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Patient Affairs Staff (PAS) in the Office of Clinical Policy and Programs (OCPP).

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November 24, 2020 at 09:45PM Real-World Evidence

Real-world data (RWD) and real-world evidence (RWE) played an increasing role in health care decisions. The 21st Century Cures Act, passed in 2016, placed additional focus on the use of these types of data to support regulatory decision making.

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Madison East student dies of COVID, district officials say - Channel3000.com - WISC-TV3

1. Madison East student dies of COVID, district officials say  Channel3000.com - WISC-TV3
2. Here's our list of at least 84 Utah schools that have had a COVID-19 outbreak or closed as a precaution  Salt Lake Tribune
3. Madison East High School student dies of COVID-19-related illness, principal says  Madison.com
4. Cheat codes Students search for shortcuts as virtual schooling expands  Oklahoman.com
5. Pennsylvania schools have until today to certify they can protect students from COVID  wgaltv
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Look-ahead lines favor Alabama over College Football Playoff contenders - AL.com

1. Look-ahead lines favor Alabama over College Football Playoff contenders  AL.com
2. AP Top 25 college football poll reaction - What's next for each ranked team?  ESPN
3. BM5: Will OSU-MSU game be played? Buckeyes headed for CFP?  247Sports
4. Buckeyes Recap: What's next for Ohio State football after cancelled game, COVID-19  ABC6OnYourSide.com
5. AP Top 25 ballot breakdown: All eyes on Ohio State after COVID-19 outbreak  NJ.com
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Ravens WR Willie Snead reportedly tests positive for COVID-19; 7th offensive starter to be sidelined amid outbreak - Baltimore Sun

1. Ravens WR Willie Snead reportedly tests positive for COVID-19; 7th offensive starter to be sidelined amid outbreak  Baltimore Sun
2. Baltimore Ravens mark eighth straight day of outbreak as WR Willie Snead IV tests positive  ESPN
3. Kovacevic: Hey ... um ... we really sure about all this?  DKPittsburghSports.com
4. Two More Ravens Players Added To COVID-19 List  WJZ
5. Sources - Baltimore Ravens-Pittsburgh Steelers game still on for Tuesday despite COVID-19 outbreak  ESPN
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Gov. Cuomo says New York’s numbers continue to rise, looks ahead to ‘Winter Phase’ - WIVB.com - News 4

1. Gov. Cuomo says New York’s numbers continue to rise, looks ahead to ‘Winter Phase’  WIVB.com - News 4
2. Coronavirus Numbers In Tri-State Area: Nov. 28, 2020  CBS New York
3. Western New York region still has the highest COVID-19 infection rate in New York State  WGRZ.com
4. New York hits highest COVID-19 positive-test rate since May, Cuomo says  New York Post
5. COVID outbreak reaches highest positive rate since May: Cuomo  New York Daily News
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November 27, 2020 at 04:09PM Field Science - Laboratory Manual

The Laboratory Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used as an agency policy for testing consumer products, training of laboratory staff, report writing, safety, research, review of private laboratory reports and cour

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Reports: Ravens QB Lamar Jackson tests positive for COVID-19, team shutting down training facilities until Mon - WPXI Pittsburgh

1. Reports: Ravens QB Lamar Jackson tests positive for COVID-19, team shutting down training facilities until Mon  WPXI Pittsburgh
2. With Ravens-Steelers game in jeopardy, what could the NFL do? Here are the options.  Baltimore Sun
3. Sources - Baltimore Ravens QB Lamar Jackson tests positive for COVID-19  ESPN
4. Report: Lamar Jackson tests positive for the coronavirus  WAVE 3
5. Ravens reportedly 'rattled' by COVID outbreak, have closed...  Larry Brown Sports
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Late for Work 11/26: Steelers Players Upset With NFL's Decision to Postpone Game - BaltimoreRavens.com

1. Late for Work 11/26: Steelers Players Upset With NFL's Decision to Postpone Game  BaltimoreRavens.com
2. BREAKING: Steelers-Ravens Thanksgiving Game postponed until Sunday | CBS Sports HQ  CBS Sports HQ
3. Ravens Discipline Staff Member for Conduct Amid COVID-19 Outbreak  Bleacher Report
4. Thanksgiving Football Game Sidelined By Covid-19 | MTP Daily | MSNBC  MSNBC
5. Ravens-Steelers game moved from Thursday night to Sunday  Yahoo Sports
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Postponement adds to quirky, sad history of Steelers' Thanksgiving Day games - TribLIVE

1. Postponement adds to quirky, sad history of Steelers' Thanksgiving Day games  TribLIVE
2. Source - More positive coronavirus tests found among Baltimore Ravens  ESPN
3. Ravens vs. Steelers scouting report for Week 12: Who has the edge?  Baltimore Sun
4. Ravens Discipline Employee in Connection with COVID-19 Outbreak  erienewsnow.com
5. Baltimore Ravens' game against Pittsburgh Steelers moved as team disciplines staffer  ESPN
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Thanksgiving NFL viewer's guide: Everything you need to know about Thursday's games - USA TODAY

1. Thanksgiving NFL viewer's guide: Everything you need to know about Thursday's games  USA TODAY
2. Ravens Discipline Staff Member for Conduct Amid COVID-19 Outbreak  Bleacher Report
3. Steelers players tweet in reaction to the postponement of Thanksgiving game vs. Ravens | GetUp  ESPN
4. NFL Makes Decision On Thanksgiving Day Kickoff Times  The Spun
5. BREAKING: Steelers-Ravens Thanksgiving Game postponed until Sunday | CBS Sports HQ  CBS Sports HQ
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Steelers-Ravens Thanksgiving Game Postponed To Sunday After Coronavirus Outbreak - NPR

Steelers-Ravens Thanksgiving Game Postponed To Sunday After Coronavirus Outbreak  NPRView Full Coverage on Google News

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November 25, 2020 at 09:08PM 2020 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

This is the main page for the CBER 2020 Meeting Materials, Vaccines and Related Biological Products Advisory Committee.

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November 25, 2020 at 09:07PM Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement - 12/10/2020 - 12/10/2020

This is the CBER Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement.

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November 25, 2020 at 04:21PM 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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November 24, 2020 at 10:53PM Safety and Effectiveness of Gene Therapy

A description of Andrew Byrnes' research program and related publications.

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November 24, 2020 at 09:45PM Impact of Immunity Induced by Viral and DNA Products

A description of Suzanne Epstein's research program and related publications.

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November 24, 2020 at 08:20PM Application Submissions Guidances

This page lists Application Submissions Guidance documents.

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More than 2,400 workers at world's top glove maker test positive for coronavirus - CBS News

1. More than 2,400 workers at world's top glove maker test positive for coronavirus  CBS News
2. Major glove factories close after thousands of workers test positive for COVID-19 | TheHill  The Hill
3. Virus outbreak delays production at world's top glove maker  NBC Montana
4. Covid-19: World's top latex glove maker shuts factories  BBC News
5. More than 1K workers at world's top surgical glove maker get COVID-19  New York Post
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Colorado order allows hospitals to stop admitting, transfer patients when at capacity due to COVID-19 | TheHill - The Hill

1. Colorado order allows hospitals to stop admitting, transfer patients when at capacity due to COVID-19 | TheHill  The Hill
2. Gov. Polis signs order allowing CDPHE to stop admissions at hospitals that have reached capacity  FOX 31 Denver
3. Polis issues order allowing at-capacity Colorado hospitals to transfer patients, deny new admissions  The Denver Channel
4. Polis signs order allowing state to order hospitals to transfer or stop seeing more patients in light of COVID outbreak  9News.com KUSA
5. Transcript: Coronavirus: Leadership During Crisis with Colorado Gov. Jared Polis  Washington Post
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November 23, 2020 at 11:17PM 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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November 23, 2020 at 11:14PM FDA Patient Engagement Opportunities

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

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November 23, 2020 at 08:51PM FDA Voices on Policy

FDA Voices on Policy

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November 23, 2020 at 06:01PM 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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Covid world map: which countries have the most coronavirus cases and deaths? - The Guardian

1. Covid world map: which countries have the most coronavirus cases and deaths?  The Guardian
2. Senior living facilities continue to see COVID-19 outbreaks despite virus protocols  41 Action News
3. Trump tweets Don Jr doing well after coronavirus infection  SF Gate
4. Are COVID-19 'lockdowns' the right response to fight the growing pandemic? | Pro/Con  The Philadelphia Inquirer
5. The Latest: Donald Trump Jr. doing 'very well' with virus  Yahoo News
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Covid world map: which countries have the most coronavirus cases and deaths? - The Guardian

1. Covid world map: which countries have the most coronavirus cases and deaths?  The Guardian
2. How is the COVID-19 pandemic affecting small business?  WXYZ-TV Detroit | Channel 7
3. The Latest: Texas tops 8,000 hospitalized virus patients  STLtoday.com
4. Are COVID-19 'lockdowns' the right response to fight the growing pandemic? | Pro/Con  The Philadelphia Inquirer
5. Senior living facilities continue to see COVID-19 outbreaks despite virus protocols  41 Action News
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November 20, 2020 at 10:54PM Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate

FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10, 2020 to discuss Pfizer and BioNTech’s emergency use authorization request for a COVID-19 vaccine.

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November 20, 2020 at 07:28PM Dr. Hahn’s Remarks to the Meeting of the Regulatory Affairs Professionals Society (RAPS) - 11/17/2020

Remarks by Stephen Hahn, MD, Commissioner of Food and Drugs, Meeting of the Regulatory Affairs Professionals Society (RAPS), Nov. 17, 2020, Washington, DC

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November 20, 2020 at 07:16PM Emergency Use Authorization for Vaccines Explained

FDA recognizes the gravity of the current public health emergency and the importance of facilitating availability, as soon as possible, of vaccines to prevent COVID-19 - vaccines that the public will trust and have confidence in receiving.

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November 20, 2020 at 06:54PM Vaccines

CBER regulates vaccine products. Vaccine information includes a listing of vaccines approved for marketing, questions about vaccines, vaccine safety and availability, and vaccine-related guidance documents, notices, and rules.

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Maryland and Virginia nursing homes battle explosive covid-19 outbreaks — again - The Washington Post

1. Maryland and Virginia nursing homes battle explosive covid-19 outbreaks — again  The Washington Post
2. Not just COVID: Nursing home neglect deaths surge in shadows  Associated Press
3. Long-term care facilities remain at center of COVID fight  KOCO Oklahoma City
4. Texas nursing homes seeing rise in coronavirus cases  KPRC Click2Houston
5. Chicago area nursing homes struggle to keep COVID-19 out of facilities  WGN News
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November 20, 2020 at 06:39PM Biologics License Applications (BLA) Process (CBER)

The Biologics License Application is used to request permission to introduce, or deliver a biologic product into interstate commerce.

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November 20, 2020 at 04:51PM Vaccine Development – 101

Details the approval process for a vaccine product.

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November 20, 2020 at 04:00PM Vibrant Health Care, Inc. - 608426 - 11/18/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

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As the U.S. nears the 200,000 daily case mark, Americans are urged to avoid Thanksgiving travel. - The New York Times

1. As the U.S. nears the 200,000 daily case mark, Americans are urged to avoid Thanksgiving travel.  The New York Times
2. CDC recommends against travel for Thanksgiving  CNN
3. CDC urges Americans against traveling for Thanksgiving as coronavirus outbreak worsens  CNBC
4. A Bright-Red Map and a Dire Warning as the Coronavirus Task Force Meets at the White House  The New York Times
5. CDC pleads with Americans to avoid Thanksgiving travel  The Associated Press
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Sweden mink industry workers test positive for COVID-19 amid mutant outbreak - New York Post

1. Sweden mink industry workers test positive for COVID-19 amid mutant outbreak  New York Post
2. Danish Agriculture Minister Resigns Amid Criticism For Ordering Mink Cull  NPR
3. The culling of minks in Denmark prompts a political crisis.  The New York Times
4. Denmark says mutated coronavirus from mink farms most likely extinct  Yahoo News
5. Danish PM taps new minister after mink culling fiasco  Associated Press
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Michigan deputy fired after sharing racist photo of Kamala Harris watermelon Jack-O’-Lantern - Yahoo News

1. Michigan deputy fired after sharing racist photo of Kamala Harris watermelon Jack-O’-Lantern  Yahoo News
2. 'We want to take the stress away': Sacramento restaurants offer Thanksgiving takeout  KCRA Sacramento
3. AOC, Nikki Haley clashed over govt funds to expedite COVID-19 relief - Business Insider  Business Insider
4. Illinois Sen. Duckworth says 'silence is deafening' from Republicans on Trump's election maneuvers  Yahoo News
5. Coos County Nursing Hospital needs staff, PPE as they deal with COVID-19 outbreak  WMUR Manchester
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Sweden mink industry workers test positive for COVID-19 amid mutant outbreak - New York Post

1. Sweden mink industry workers test positive for COVID-19 amid mutant outbreak  New York Post
2. Danish Agriculture Minister Resigns Amid Criticism For Ordering Mink Cull  NPR
3. The culling of minks in Denmark prompts a political crisis.  The New York Times
4. Denmark says mutated coronavirus from mink farms most likely extinct  Yahoo News
5. Danish PM taps new minister after mink culling COVID-19 fiasco  Los Angeles Times
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CDC warns America: Do not travel for Thanksgiving - NBC News

1. CDC warns America: Do not travel for Thanksgiving  NBC News
2. CDC urges Americans against traveling for Thanksgiving as coronavirus outbreak worsens  CNBC
3. CDC recommends against travel for Thanksgiving  CNN
4. Covid-19 News: Live Updates  The New York Times
5. U.S. disease experts: Don't travel for Thanksgiving  Yahoo News
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November 19, 2020 at 09:45PM Vaccine Notices, Proposed and Final Rules

List of vaccine notices, proposed and final rules

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November 19, 2020 at 08:44PM Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases

Testing HCT/P Donors for Relevant Communicable Diseases

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CDC urges Americans against traveling for Thanksgiving as coronavirus outbreak worsens - CNBC

1. CDC urges Americans against traveling for Thanksgiving as coronavirus outbreak worsens  CNBC
2. CDC advises Americans not to travel for Thanksgiving  Axios
3. CDC updates coronavirus Thanksgiving guidance, urges against travel  Fox News
4. CDC's New Guidance: Do Not Travel for Thanksgiving  The Daily Beast
5. CDC updates Thanksgiving guidance, recommends that Americans do not travel after US passes grim milestone of 250,000 COVID 19 deaths  WPVI-TV
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Diversions and transfer delays plague hospitals overwhelmed by Covid-19 cases - NBC News

1. Diversions and transfer delays plague hospitals overwhelmed by Covid-19 cases  NBC News
2. 'Tired to the bone': Hospitals overwhelmed with virus cases  The Associated Press
3. Outbreak: Hospitals are overwhelmed, staff is ‘tired to the bone’  The Mercury News
4. Hospitals try to find space as they’re overwhelmed with coronavirus patients  cleveland.com
5. U.S. surpasses 250,000 deaths from COVID-19 as infections surge  ABC27
6. View Full Coverage on Google News

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November 19, 2020 at 02:49PM Cross Labeling Oncology Drugs in Combination Regimens Guidance for Industry

Guidance for Industry - Clinical Medical

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November 19, 2020 at 02:47PM Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act

Biosimilarity

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November 18, 2020 at 10:19PM TRG Rapid Inquiry Program (TRIP)

As a result of the July 2020 update to the FDA's guidance document, "Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue- Based Products: Minimal Manipulation and Homologous Use," FDA is extending the TRIP program through March 31, 2021.

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New York City to Close Public Schools Again as Virus Cases Rise - The New York Times

1. New York City to Close Public Schools Again as Virus Cases Rise  The New York Times
2. Mayor de Blasio, schools chancellor hold coronavirus update in NYC  Eyewitness News ABC7NY
3. New York City will close schools for in-person learning to curb Covid outbreak, Mayor de Blasio says  CNBC
4. NYC schools to close for COVID-19  New York Daily News
5. NYC Mayor De Blasio Holds Daily Briefing  NBC New York
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November 18, 2020 at 07:17PM Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND

This guidance is intended to assist clinical investigators, sponsors, sponsor-investigators, and institutional review boards (IRBs) in determining whether research studies involving human subjects must be conducted under an investigational new drug application (IND).

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'No Second Chance To Stop A Second Wave': South Australia Enters 6-Day Lockdown : Coronavirus Updates - NPR

1. 'No Second Chance To Stop A Second Wave': South Australia Enters 6-Day Lockdown : Coronavirus Updates  NPR
2. South Australia to enter strict "circuit breaker" lockdown  Axios
3. New national hotel quarantine worker testing rules announced – as it happened  The Guardian
4. Adelaide cricket Test against India in fresh doubt as South Australia enters lockdown  The Guardian
5. Adelaide Test in balance as Cricket Australia rushes players into NSW amid Covid outbreak  The Guardian
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November 18, 2020 at 05:28PM Getting Started with ICSR Submission to FDA’s electronic Vaccine Adverse Event Reporting System (eVAERS)

Follow the steps below for submitting ICSRs to the FDA's electronic Vaccine Adverse Event Reporting System (eVAERS).

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November 18, 2020 at 05:21PM CBER Vaccine ICSR Implementation

The CBER ICSR Implementation webpage was created to provide current information about CBER’s progress toward the adoption and implementation of the ISO/HL7 Individual Case Safety Report (ICSR) standard and the ICH E2B(R3) revised content specification to support electronic reporting to the Vaccine Adverse Event Reporting System (VAERS)

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November 18, 2020 at 03:07PM Emergency Use Authorization for Vaccines to Prevent COVID-19

This is the Guidance for Industry for the Emergency Use Authorization for Vaccines to Prevent COVID-19. , COVID-19, Coronavirus Disease 2019, Vaccines , CBER, Biologics

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November 17, 2020 at 10:30PM 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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November 17, 2020 at 10:03PM Health Fraud Scams

Learn how to spot health fraud and avoid it.

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November 17, 2020 at 12:02AM Coronavirus (COVID-19) Update: November 16, 2020

Coronavirus (COVID-19) Update

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November 16, 2020 at 09:21PM Blood Guidances

This page contains a listing of Blood Guidances guidances.

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November 16, 2020 at 09:21PM 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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November 16, 2020 at 02:51PM Electromagnetic Compatibility (EMC) of Medical Devices

FDA is issuing this guidance to recommend information that should be provided in a premarket submission to demonstrate electromagnetic compatibility.

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Some states impose new restrictions as U.S. tops 11 million COVID-19 cases - CBS News

1. Some states impose new restrictions as U.S. tops 11 million COVID-19 cases  CBS News
2. Coronavirus updates: State reports highest single-day case total; Inslee to announce new restrictions  Tacoma News Tribune
3. Prairie Meadows temporarily bans smoking due to rising COVID-19 cases  KCCI
4. Virus Outbreak: News and Analysis From Nov. 16, 2020  Bloomberg
5. ICU beds reaching capacity in some parts of U.S. as COVID-19 cases surge  CBS Evening News
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COVID-19 updates: Dallas County reports highest single-day case total yet - WFAA.com

1. COVID-19 updates: Dallas County reports highest single-day case total yet  WFAA.com
2. N.J. hits record number of new COVID-19 cases with 4,395 positive tests, 26 deaths  NJ.com
3. More than 184,000 COVID-19 cases reported in U.S. in one day, shattering previous record  CBS News
4. Erie County Sees Record 149 New Coronavirus Cases; State Reports New Single-Day High Increase  erienewsnow.com
5. Virus Outbreak: News and Analysis From Nov. 15, 2020  Bloomberg
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November 13, 2020 at 11:17PM Certificates of Confidentiality

This guidance describes FDA implementation of the revised provisions applicable to the request for, and issuance of, a Certificate of Confidentiality (CoC).

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November 13, 2020 at 06:17PM 2020 Meeting Materials, Blood Products Advisory Committee

This is the main page for CBER's 2020 Meeting Materials, Blood Products Advisory Committee.

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More than 130 Secret Service officers are said to be infected with coronavirus or quarantining in wake of Trump’s campaign travel - The Washington Post

1. More than 130 Secret Service officers are said to be infected with coronavirus or quarantining in wake of Trump’s campaign travel  The Washington Post
2. More than 130 Secret Service officers in quarantine: report | TheHill  The Hill
3. The Latest: More than 130 Secret Service officers infected or quarantining in wake of Trump's campaign travel  pressherald.com
4. Over 130 Secret Service agents isolating amid White House COVID-19 outbreak  New York Post
5. View Full Coverage on Google News

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November 13, 2020 at 03:40PM Vaccination Is the Best Protection Against Measles

Measles is not a harmless childhood disease. It's dangerous and can be life-threatening. Our most effective public health measure against measles is prevention with the measles vaccine.

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November 13, 2020 at 03:40PM Vaccination Is the Best Protection Against Measles

Measles is not a harmless childhood disease. It's dangerous and can be life-threatening. Our most effective public health measure against measles is prevention with the measles vaccine.

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November 13, 2020 at 03:35PM 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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November 12, 2020 at 03:59PM Stakeholders in the highly competitive citrus market are pulling together at the international level to ensure the sustainability of the sector

The first edition of the Global Citrus Congress, co-organised by the World Citrus Organisation (WCO), CIRAD and Fruitnet Media International, was held in early November. More than 1 300 participants from 60 producing countries joined this entirely virtual event. Growth in supply is outstripping growth in demand on the international citrus market. Faced with the risk of saturation in certain parts of the market, stakeholders in the sector are working to achieve greater transparency between producers, as well as to promote their products to consumers.

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November 13, 2020 at 11:26AM Tribune | «Il faut institutionnaliser le concept “One Health” pour prévenir de nouvelles épidémies à l’échelle mondiale»

Un collectif de chercheurs, de médecins et de vétérinaires estime, dans une tribune au « Monde », que la gestion des épidémies émergentes nécessite une approche globale, baptisée « One Health », qui intègre différents secteurs et disciplines des santés humaine, animale, végétale et environnementale. Thierry Lefrançois, expert des approches intégrées et des réseaux de santé au Cirad, fait partie des signataires de la tribune.

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November 13, 2020 at 11:26AM Thierry Lefrançois : «Le lancement du Conseil d’experts de haut niveau Une seule santé constitue une étape essentielle pour la prévention des épidémies mondiales»

La création d’un Conseil d’experts de haut niveau One Health/Une seule santé vient d’être annoncée dans le cadre du Forum de la paix de Paris 2020. Ce conseil plébiscité par les scientifiques constitue un espoir majeur dans la prévention et la gestion des futures épidémies mondiales. Précisions avec Thierry Lefrançois, expert des approches intégrées et des réseaux de santé au Cirad.

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Corey Lewandowski tests positive for coronavirus - POLITICO

1. Corey Lewandowski tests positive for coronavirus  POLITICO
2. Two more people from Trump's Election Night party at White House test positive for coronavirus  CNBC
3. White House Outbreaks Persist, as Cases Now Span Three Months  The New York Times
4. Trump aides privately plot a flurry of moves in their final 10 weeks  POLITICO
5. 2 White House aides and guest of Rudy Giuliani test positive for coronavirus  Chicago Tribune
6. View Full Coverage on Google News

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Trump advisor Corey Lewandowski tests positive for coronavirus - CNBC

1. Trump advisor Corey Lewandowski tests positive for coronavirus  CNBC
2. White House Outbreaks Persist, as Cases Now Span Three Months  The New York Times
3. The government’s coronavirus response is now officially a failure by its own measure  The Washington Post
4. Two more people from Trump's Election Night party at White House test positive for coronavirus  CNBC
5. Trump campaign adviser Corey Lewandowski tests positive for coronavirus | TheHill  The Hill
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November 12, 2020 at 05:39PM ASSET : vers des systèmes alimentaires et agricoles plus durables en Asie du Sud-Est

Les systèmes agricoles et alimentaires d’Asie du Sud-Est sont à la croisée des chemins, entre des modèles d’intensification conventionnels et des initiatives agroécologiques innovantes. Mis en œuvre par 27 partenaires au Cambodge, Laos, Myanmar et Vietnam, le projet ASSET explore, pendant 5 ans, la transition vers des systèmes plus durables, d’un point de vue social, environnemental et sanitaire.

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November 12, 2020 at 03:59PM Les acteurs du marché très concurrentiel des agrumes s’organisent au niveau international pour assurer la durabilité de la filière

La première édition du Global Citrus Congress, co-organisé par la World Citrus Organisation (WCO), le Cirad et Fruitnet Media International, s’est tenue début novembre. Plus de 1300 participants en provenance de 60 pays producteurs ont rejoint l’évènement entièrement virtuel. Le marché international des agrumes connaît une croissance de son offre supérieure à la croissance de la demande. Face à un risque de saturation de certains pans du marché, les acteurs de la filière misent sur plus de transparence entre les producteurs, ainsi que sur la promotion de leurs produits auprès des consommateurs.

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November 12, 2020 at 03:25PM Protect Your Family From Fraudulent Flu Products

Influenza season may bring out dishonest sellers hawking fraudulent products that claim to prevent, treat, or cure the flu. These unproven products, sold online and in stores, haven’t been evaluated by the FDA for safety and effectiveness.

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November 12, 2020 at 03:25PM Protect Your Family From Fraudulent Flu Products

Influenza season may bring out dishonest sellers hawking fraudulent products that claim to prevent, treat, or cure the flu. These unproven products, sold online and in stores, haven’t been evaluated by the FDA for safety and effectiveness.

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Trump’s team rushes to execute lame-duck moves — even without a concession - POLITICO

1. Trump’s team rushes to execute lame-duck moves — even without a concession  POLITICO
2. Two more people from Trump's Election Night party at White House test positive for coronavirus  CNBC
3. White House Outbreaks Persist, as Cases Now Span Three Months  The New York Times
4. White House political director tests positive for coronavirus, official says  CNN
5. Four Trump Allies Have Now Tested Positive for COVID-19 After Election Night Party  The Daily Beast
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Providence Medical Center reports COVID-19 outbreak within hospital - KOMO News

Providence Medical Center reports COVID-19 outbreak within hospital  KOMO NewsView Full Coverage on Google News

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Coronavirus: Denmark shaken by cull of millions of mink - BBC News

1. Coronavirus: Denmark shaken by cull of millions of mink  BBC News
2. About a dozen US mink farms in quarantine as officials probe COVID-19 outbreaks  New York Post
3. Denmark shelves plans to cull up to 17 million mink over coronavirus concerns | TheHill  The Hill
4. Denmark mink cull: Government admits culling had no legal basis  BBC News
5. Coronavirus kills 15,000 U.S. mink, as Denmark prepares for nationwide cull  Yahoo News
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As Hospitalizations Soar, El Paso Brings In New Mobile Morgues - The New York Times

1. As Hospitalizations Soar, El Paso Brings In New Mobile Morgues  The New York Times
2. El Paso, Texas, is asking for 4 more mobile morgues as Covid-19 deaths spike  CNN
3. El Paso County grapples with surge of coronavirus cases: "They're worried they may be next"  CBS News
4. Colorado jail virus outbreak infects 911 inmates, 73 workers  9News.com KUSA
5. El Paso calls in 10 refrigerated morgue trailers amid surge in coronavirus deaths: reports  Fox News
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November 10, 2020 at 06:28PM Section 8000: General Information

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

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November 10, 2020 at 05:44PM Clinical Guidances

This page lists Clinical Guidance documents.

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November 10, 2020 at 01:30AM Tuberculin, Purified Protein Derivative - TUBERSOL

The product page for Tuberculin, Purified Protein Derivative - TUBERSOL containing the labeling and supporting documents

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November 10, 2020 at 01:16AM Coronavirus (COVID-19) Update: November 9, 2020

Coronavirus (COVID-19) Update

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November 09, 2020 at 04:42PM 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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November 09, 2020 at 02:12PM Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry

User Fees

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November 09, 2020 at 10:25AM Albedo Climate Change Mitigation

Un séminaire international organisé par le Cirad et l'institut de convergence CLAND, avec le soutien de l'initiative 4P1000 et de la Global Research Alliance on Agricultural Greenhouse Gases.

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November 06, 2020 at 10:10PM Tissue & Advanced Therapies Research

This page is about Tissue & Advanced Therapies Research

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November 06, 2020 at 10:09PM Genome Editing and Advanced Manufacturing of Hematopoietic Stem Cell-Based Therapeutics

PI Webpage for Pankaj Kumar Mandal, PhD

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November 04, 2020 at 04:49PM Coronavirus Disease 2019 Testing Basics

Easy-to-understand information about the different types of coronavirus tests

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November 06, 2020 at 05:40PM Formation professionnelle | Le Cirad obtient la certification Qualiopi

Le Cirad devient l’un des premiers organismes français de recherche à bénéficier de la certification Qualiopi. Délivré par l’Afnor, ce label officiel atteste de la qualité des formations professionnelles dispensées.

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November 05, 2020 at 09:51PM Biological Product Deviation Guidances & Rules

List of Biological Product Deviation Guidances & Rules

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November 05, 2020 at 06:34PM 3e Congrès international d'horticulture - IHC 2022

Organisé en partenariat avec le Cirad.

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November 05, 2020 at 05:10PM Biologics PREA Reviews and Labeling Changes

PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under section 505 of the Act and biological drugs licensed under section 351 of the Public Health Service Act.

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November 05, 2020 at 06:07PM Le genre en recherche - Évaluation et production des savoirs

Une journée de présentations et d’échanges sur les outils et méthodes pour réduire les biais de genre, organisée par le Cirad et l'ANR dans le cadre du projet européen Gender-SMART.

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November 05, 2020 at 05:04PM FDA 101: How to Use the Consumer Complaint System and MedWatch

If you have a complaint about a product regulated by the Food and Drug Administration (FDA), the agency wants to hear about it.

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November 05, 2020 at 04:13PM FDA Patient Engagement Overview*

FDA Patient Engagement Overview

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November 05, 2020 at 04:01PM Charter of the Cellular, Tissue and Gene Therapies Advisory Committee

This is the charter for CBER's Cellular, Tissue and Gene Therapies Advisory Committee.

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November 05, 2020 at 04:33PM FDA 101: How to Use the Consumer Complaint System and MedWatch

Advice on using FDA's Consumer Complaint System and MedWatch.

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COVID-19 death toll in Oregon hits 705; outbreak reported at Fred Meyer Distribution Center in Clackamas Co. - KPTV.com

1. COVID-19 death toll in Oregon hits 705; outbreak reported at Fred Meyer Distribution Center in Clackamas Co.  KPTV.com
2. November 4 coronavirus news  CNN
3. McPherson County reports 58 new cases of COVID-19; 1 additional death  Salina Post
4. 'It is everywhere': As COVID-19 cases surge, Allegheny County health official urges precautions  Pittsburgh Post-Gazette
5. England locks back down, Italy puts regions on red alert as Covid-19 deaths spike 43% in Europe  CNN
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