November 30, 2021 at 04:13PM Coronavirus (COVID-19) Update: FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and Boosters

FDA is working with federal partners, international regulators and medical product companies to quickly address any potential impacts of the omicron variant.

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NFL Week 13 Power Rankings: All seems right as Packers, Buccaneers, Chiefs and Bills earn spots in Top 10 - CBSSports.com

1. NFL Week 13 Power Rankings: All seems right as Packers, Buccaneers, Chiefs and Bills earn spots in Top 10  CBSSports.com
2. NFL Power Rankings Week 13 - 1-32 poll, plus checking in on each team's confidence rating  ESPN
3. Week 13 NFL power rankings: Packers return to No. 1 spot, Patriots top AFC field  USA TODAY
4. NFL Week 12 winners and losers, plus Cowboys dealing with COVID outbreak and Seahawks-Washington 'MNF' picks  CBSSports.com
5. Judging NFL Week 12 overreactions - Is Bill Belichick the Coach of the Year? Is Baltimore the best team in the AFC? Could the Rams miss the playoffs?  ESPN

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Omicron poses ‘very high’ risk of new COVID-19 outbreaks, top global health official warns - oregonlive.com

1. Omicron poses ‘very high’ risk of new COVID-19 outbreaks, top global health official warns  oregonlive.com
2. Why WHO skipped two letters of the Greek alphabet in naming Omicron  CNN
3. Omicron: WHO warns of 'high infection risk' around globe  BBC News
4. COVID omicron variant – how worried should you be?  Fox News
5. World takes decisive action against Omicron as new variant prompts fears of another COVID wave  CBS Mornings

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November 29, 2021 at 07:32PM BK210574 - LIFECODES LSA Class II

LIFECODES LSA Class II Beads are designed to detect IgG antibodies to HLA Class II glycoproteins. LSA Class II is composed of different Luminex Beads to which purified recombinant Class II HLA glycoproteins are conjugated.

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November 29, 2021 at 07:31PM BK210573 - LIFECODES LSA Class I

LIFECODES LSA Class I Beads are designed to detect IgG antibodies to HLA Class I glycoproteins. LSA Class I is composed of different Luminex Beads to which purified recombinant Class I HLA glycoproteins are conjugated.

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November 29, 2021 at 07:28PM BK210572 - MATCH IT! Antibody

The BK210572 - MATCH IT! Antibody Software is an optional accessory to aid in the evaluation of test results from Immucor GTI Diagnostics, Inc. LIFECODES® Antibody detection kits for use with Luminex.

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November 29, 2021 at 03:36PM CBER Biologics Effectiveness and Safety (BEST) System

This is the main page for CBER's Biologics Effectiveness and Safety (BEST) System.

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November 29, 2021 at 02:49PM Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry

Real-World Data/Real-World Evidence (RWD/RWD) and Clinical/Medical

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China study warns of 'colossal' COVID outbreak if it opens up like U.S., France - Reuters

1. China study warns of 'colossal' COVID outbreak if it opens up like U.S., France  Reuters
2. Covid-19 in China: Country Risks Huge Outbreak on US-Style Reopening  Bloomberg
3. China Could See Over 630K Daily COVID Infections if It Drops Zero-Tolerance Goal: Study  Newsweek

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WTO postpones key ministers meeting over omicron variant | TheHill - The Hill

1. WTO postpones key ministers meeting over omicron variant | TheHill  The Hill
2. WTO postpones major meeting after new variant outbreak  Reuters
3. WTO delays key meeting amid COVID variant concerns  Yahoo News
4. WTO Postpones Geneva Ministerial Meeting Over Virus Concerns  Bloomberg
5. Postponed WTO meeting complicates USTR Tai's push for new dynamism at trade body  Reuters

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November 24, 2021 at 04:41PM Principal Investigator – Viral Vaccines

CBER is recruiting to fill multiple Principal Investigator (Research/Review Scientist) positions within the Division of Viral Products (DVP).

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November 24, 2021 at 12:45PM Surgenex LLC - 615254 - 11/15/2021

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


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November 23, 2021 at 11:17PM TRUMENBA

Indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Trumenba is approved for use in individuals 10 through 25 years of age.

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November 19, 2021 at 07:24PM FDALabel: Full-Text Search of Drug Product Labeling

FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 140,000 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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November 19, 2021 at 06:10PM Janssen COVID-19 Vaccine Frequently Asked Questions

Answers to frequently asked questions about FDA's Emergency Use Authorization of the Janssen COVID-19 Vaccine, manufactured by Janssen Biotech, Inc., a Janssen Pharmaceutical Company of Johnson & Johnson

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November 19, 2021 at 02:41PM Coronavirus (COVID-19) Update: FDA Expands Eligibility for COVID-19 Vaccine Boosters

The FDA amended the emergency use authorizations for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.

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Market in China's Wuhan likely origin of COVID-19 outbreak - study - Reuters

1. Market in China's Wuhan likely origin of COVID-19 outbreak - study  Reuters
2. First Known Covid Case Was Vendor at Wuhan Market, Scientist Says  The New York Times
3. Fresh look at pandemic origins points straight to food market in Wuhan, scientist says  CNN
4. U.S. scientist says he's found the real COVID patient zero, and "strong evidence" pandemic started at animal market  CBS News
5. Leading scientist argues first coronavirus cases point to Wuhan market origin  The Washington Post

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November 18, 2021 at 09:38PM Moderna COVID-19 Vaccine Frequently Asked Questions

Answers to questions about the FDA's Emergency Use Authorization of the Moderna COVID-19 vaccine

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November 18, 2021 at 08:05PM Learn More About COVID-19 Vaccines From the FDA

Get answers to your questions about the standards for safety and effectiveness to support an emergency use authorization of COVID-19 vaccines.

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November 18, 2021 at 05:44PM Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments

Fraudulent products that claim to cure, treat, or prevent COVID-19 haven’t been evaluated by the FDA for safety and effectiveness and might be dangerous to you and your family.

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November 18, 2021 at 05:37PM Help Stop the Spread of Coronavirus and Protect Your Family

We can each take simple steps to slow the spread of COVID-19 and protect ourselves, our families and our communities. Get a COVID-19 vaccine. Wash your hands often. Cover your mouth and nose with a mask when around others. Avoid crowds and practice social distancing.

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November 17, 2021 at 08:52PM Patient Engagement Collaborative

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

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November 18, 2021 at 03:04PM Emergency Dispensing Orders and Emergency Use Instructions (EUI)

The emergency dispensing order authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of eligible, approved MCMs needed during public health emergencies without FDA needing to issue an Emergency Use Authorization.

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November 17, 2021 at 09:37PM 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 17, 2021 at 06:31PM 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 17, 2021 at 06:16PM Emergency Dispensing Orders and Emergency Use Information (EUI)

The emergency dispensing order authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of eligible, approved MCMs needed during public health emergencies without FDA needing to issue an Emergency Use Authorization.

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November 16, 2021 at 10:04PM Procleix Ultrio Elite Assay

•Intended to screen for human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA and to detect human immunodeficiency virus type 2 (HIV-2) RNA, in plasma and serum specimens from individual human donors, including donors of whole blood, blood compo

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November 16, 2021 at 09:09PM Vaccines and Related Biological Products Advisory Committee March 5, 2021 Meeting Announcement - 03/05/2021 - 03/05/2021

This is the CBER Vaccines and Related Biological Products Advisory Committee March 5, 2021 Meeting Announcement.

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Connecticut nursing home COVID-19 outbreak results in 89 infected, 8 dead - ABC News

1. Connecticut nursing home COVID-19 outbreak results in 89 infected, 8 dead  ABC News
2. 8 deaths reported after recent Covid-19 outbreak at a Connecticut nursing home  CNN
3. CT Nursing Home Reports 8 COVID-Related Deaths After Virtually All Residents & Staff Were Vaccinated  CBS New York
4. COVID Outbreak at Connecticut Nursing Home Kills 8, Infects Dozens  The Daily Beast
5. 8 dead, 89 infected after Covid outbreak at Connecticut nursing home  NBC News
6. View Full Coverage on Google News

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China locks down university campus amid new COVID-19 outbreak - Fox News

China locks down university campus amid new COVID-19 outbreak  Fox NewsView Full Coverage on Google News

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November 15, 2021 at 09:39PM Multilingual COVID-19 Vaccines Myths Social Media Toolkit

COVID-19 Vaccines Myths social media toolkit in English, Spanish, Chinese, Korean, Vietnamese and Tagalog.

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November 15, 2021 at 04:10PM Cellular, Tissue, and Gene Therapies Advisory Committee September 2-3, 2021 Meeting Announcement - 09/02/2021 - 09/03/2021

This is the CBER Cellular, Tissue, and Gene Therapies Advisory Committee September 2-3, 2021 Meeting Announcement.

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Austria locks down unvaccinated as COVID cases rise across Europe - Reuters

1. Austria locks down unvaccinated as COVID cases rise across Europe  Reuters
2. Austria On Lockdown ForThe Unvaccinated  NBC News
3. Austria orders nationwide lockdown for the unvaccinated  Yahoo News
4. Austria imposes nationwide lockdown on unvaccinated citizens  CBS Evening News
5. Virus Outbreak: News and Analysis From Nov. 15  Bloomberg

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New outbreak prompts China to lock down university campus - Associated Press

New outbreak prompts China to lock down university campus  Associated PressView Full Coverage on Google News

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Austria orders lockdown for residents who have not received COVID-19 vaccine - CBS News

1. Austria orders lockdown for residents who have not received COVID-19 vaccine  CBS News
2. Austria On Lockdown ForThe Unvaccinated  NBC News
3. Austria orders nationwide lockdown for the unvaccinated  WGN TV Chicago
4. Austria to impose Covid lockdown for the unvaccinated age 12 and older  CNN
5. Virus Outbreak: News and Analysis From Nov. 15  Bloomberg
6. View Full Coverage on Google News

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China fights biggest Delta outbreak as cases grow in city of Dalian - Reuters

China fights biggest Delta outbreak as cases grow in city of Dalian  ReutersView Full Coverage on Google News

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Airbus wins large order from veteran low-cost airline investor Franke - Financial Times

1. Airbus wins large order from veteran low-cost airline investor Franke  Financial Times
2. Airbus receives order for 255 jets in first major deal since Covid outbreak  CNBC
3. Breaking: Indigo Partners Reveals Huge Orders For 255 Airbus A321  Simple Flying
4. Dubai Airshow 2021: Wizz Air owner places order for 255 Airbus A321s at $33 billion list price  Gulf News
5. Dubai Airshow 2021: Airbus Orders and Announcements  Sam Chui

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Breaking: Indigo Partners Reveals Huge Orders For 255 Airbus A321 - Simple Flying

1. Breaking: Indigo Partners Reveals Huge Orders For 255 Airbus A321  Simple Flying
2. Airbus receives order for 255 jets in first major deal since Covid outbreak  CNBC
3. Dubai Airshow 2021: Airbus Orders and Announcements  Sam Chui
4. Dubai Airshow 2021: Wizz Air owner places order for 255 Airbus A321s at $33 billion list price  Gulf News
5. Airbus wins large order from veteran low-cost airline investor Franke  Financial Times
6. View Full Coverage on Google News

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Dutch gov’t orders partial lockdown amid COVID surge - Al Jazeera English

1. Dutch gov’t orders partial lockdown amid COVID surge  Al Jazeera English
2. Covid live: Netherlands to return to partial lockdown from Saturday – as it happened  The Guardian
3. Virus Outbreak: News and Analysis From November 13  Bloomberg
4. Netherlands Looks to Partial Lockdown as Covid Cases Rise  The New York Times
5. Dutch return to partial lockdown as COVID-19 cases soar  Reuters
6. View Full Coverage on Google News

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November 12, 2021 at 09:56PM Study Data Technical Conformance Guide - Technical Specifications Document

This technical specifications document represents the Food and Drug Administration's (FDA's) current thinking on this topic.

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November 11, 2021 at 04:05AM 2021_08 Test Article EDITED FT 02

2021_08 Test Article some long description some long description.

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November 10, 2021 at 09:30PM FDA Voices on Policy

FDA Voices on Policy

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November 10, 2021 at 03:20PM BIMO/Team Biologics/Internet Surveillance/Other

This is the main page for the CBER BIMO/Team Biologics/Internet Surveillance/Other.

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November 10, 2021 at 02:33PM Comirnaty

Vaccine indicated for active immunization to prevent 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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Sources -- Cleveland Browns RBs Nick Chubb, Demetric Felton test positive for COVID-19 - ESPN

1. Sources -- Cleveland Browns RBs Nick Chubb, Demetric Felton test positive for COVID-19  ESPN
2. Nick Chubb among multiple Browns sidelined following Covid-19 outbreak  Pats Pulpit
3. Browns' Nick Chubb, Demetric Felton test positive for COVID-19, leaving only 1 RB available  USA TODAY
4. Browns running backs Nick Chubb, Demetric Felton test positive for COVID; still could play vs. Patriots  cleveland.com
5. Browns Hit With COVID-19 Outbreak Ahead Of Patriots Game, With Nick Chubb And Three Other Players Testing Positive  CBS Boston

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Nick Chubb, Demetric Felton test positive for COVID-19 - NBC Sports

1. Nick Chubb, Demetric Felton test positive for COVID-19  NBC Sports
2. Sources -- Cleveland Browns RBs Nick Chubb, Demetric Felton test positive for COVID-19  ESPN
3. Browns RB Nick Chubb Tests Positive for COVID-19  Sports Illustrated
4. Cleveland Browns Nick Chubb, Demetric Felton test positive for COVID-19: reports  WJW FOX 8 News Cleveland
5. Browns Hit With COVID-19 Outbreak Ahead Of Patriots Game, With Nick Chubb And Three Other Players Testing Positive  CBS Boston

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November 09, 2021 at 05:35PM FDA Voices

Insights from FDA leadership and experts into the agency's work on policy, consumer safety & enforcement, medical products, food, & tobacco.

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November 09, 2021 at 04:21PM Guidance and Other Information of Special Interest to MCM Stakeholders

Information of particular interest to sponsors/applicants of medical countermeasures to treat, prevent, diagnose, and detect chemical, biological, radiological, and nuclear threats and emerging infectious diseases

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November 08, 2021 at 05:25PM Remarks by Acting Commissioner Janet Woodcock to the 2021 GRx+Biosims Conference - 11/08/2021

Remarks by Janet Woodcock, M.D.
Acting Commissioner of Food and Drugs
2021 GRx+Biosims Conference
Washington, DC
November 8, 2021

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Pandemic travel news: Russia and China fight record Covid outbreaks - CNN

1. Pandemic travel news: Russia and China fight record Covid outbreaks  CNN
2. Near-Daily Covid Tests, Sleeping in Classrooms: Life in Covid-Zero China  The New York Times
3. Virus Outbreak: News and Analysis From Nov. 6  Bloomberg
4. China's zero COVID policy sparks protest in a town battered by lockdowns : Goats and Soda  NPR
5. How Long Can China Chase Covid Zero? Here’s What the Experts Say  Yahoo Finance

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Coronavirus in Oregon: 19 new deaths and 1,141 new cases - OregonLive

1. Coronavirus in Oregon: 19 new deaths and 1,141 new cases  OregonLive
2. Oregon man, 36, succumbs to COVID; cases drop week-to-week  KOIN.com
3. NEW: Increase in COVID-19 test positivity rate breaks weeks-long trend in Nevada  KLAS - 8 News Now
4. Federal vaccine mandate will require millions to get vaccinated  WWLP.com
5. COVID-19 in Larimer County: Schools, health centers and more see 12 new outbreaks  Coloradoan

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November 05, 2021 at 10:57PM Patient Listening Session Summaries

Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Office of Patient Affairs draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions.

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November 05, 2021 at 09:37PM Janssen COVID-19 Vaccine

Information about the Janssen COVID-19 Vaccine, manufactured by Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson

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November 05, 2021 at 09:01PM Coronavirus (COVID-19) Update: November 5, 2021

Coronavirus (COVID-19) Update: November 5, 2021

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November 05, 2021 at 07:05PM 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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November 05, 2021 at 06:33PM CPG Sec. 110.100 Certification for Exports (Withdrawn 11/04/2021)

CPG Sec. 110.100 Certification for Exports (Withdrawn 11/04/2021)

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Odell Beckham Jr. released, will Las Vegas Raiders be interested? - Silver And Black Pride

1. Odell Beckham Jr. released, will Las Vegas Raiders be interested?  Silver And Black Pride
2. New York Giants RB Saquon Barkley back with team after false positive COVID-19 tests, but likely to sit vs. Las Vegas Raiders  ESPN
3. Giants' Joe Judge on Kadarius Toney's ill-received tweet about Henry Ruggs III: 'It's important how we articulate our words'  Yahoo Sports
4. Raiders at Giants predictions: Point spread, total, player props, trends for Week 9 matchup at MetLife Stadium  CBS Sports
5. Giants confirm false COVID-19 positives amid feared outbreak  Yardbarker

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November 05, 2021 at 03:29PM 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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November 05, 2021 at 02:15PM Moderna COVID-19 Vaccine

Information about the Moderna COVID-19 Vaccine

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November 04, 2021 at 06:26PM 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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November 04, 2021 at 07:43PM CPG Sec. 110.100 Certification for Exports

CPG Sec. 110.100 Certification for Exports

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November 04, 2021 at 07:22PM Roster of the Allergenic Products Advisory Committee

As part of the Food and Drug Administration's (FDA's) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations for members to serve on its advisory committees.

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November 04, 2021 at 01:17PM Webinars and Outreach

CBER sponsored webinars for public and industry.

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November 04, 2021 at 12:58PM 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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China doubles down on zero-Covid as it battles most widespread outbreak since Wuhan - CNN

1. China doubles down on zero-Covid as it battles most widespread outbreak since Wuhan  CNN
2. China's New Delta Outbreak Found in 19 Provinces, More Than at Any Time  Bloomberg
3. China keeps close vigil at ports of entry to cut COVID-19 risks  Reuters
4. What you need to know about the coronavirus right now  Yahoo News
5. China Fortifies Beijing as Covid Outbreaks Continue to Swell  Bloomberg

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November 03, 2021 at 09:55PM Multilingual COVID-19 Resources

The U.S. Centers for Disease Control and Prevention (CDC), and international and U.S. Government partners including FDA, are addressing an outbreak of coronavirus disease 2019 (COVID-19).

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November 03, 2021 at 09:15PM Section 8400: Marketing Applications

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

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November 03, 2021 at 08:03PM Blood Products Advisory Committee November 4, 2021 Meeting Announcement - 11/04/2021 - 11/04/2021

This is the CBER Blood Products Advisory Committee November 4, 2021 Meeting Announcement.

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November 03, 2021 at 01:27PM Blood Guidances

This page contains a listing of Blood Guidances guidances.

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November 03, 2021 at 01:10PM Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers

This the guidance Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers; Guidance for Industry

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November 02, 2021 at 10:25PM Drugs@FDA Data Files

Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

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November 02, 2021 at 10:07PM Coronavirus (COVID-19) Update: November 2, 2021

Coronavirus (COVID-19) Update: November 2, 2021

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Blackhawks, NHL mishandled sexual-assault allegations in 2020 and 2021, not just 2010 - Chicago Sun-Times

1. Blackhawks, NHL mishandled sexual-assault allegations in 2020 and 2021, not just 2010  Chicago Sun-Times
2. Gary Bettman defends NHL's disciplinary decisions in Chicago Blackhawks investigation  ESPN
3. Opinion: Gary Bettman is handling Blackhawks scandal like a lawyer, not a commissioner  USA TODAY
4. Head Of NHL Doubles Down On Blackhawks Fine, League's Actions  NBC Chicago
5. Monday LNN: Beach Meets with Bettman, Sharks COVID Outbreak, Eichel Trade  Silver Seven

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November 01, 2021 at 11:10PM Vaccines and Related Biological Products Advisory Committee October 26, 2021 Meeting Announcement - 10/26/2021 - 10/26/2021

This is the CBER Vaccines and Related Biological Products Advisory Committee October 26, 2021 Meeting Announcement.

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