February 28, 2021 at 12:11AM 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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February 28, 2021 at 12:11AM 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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February 28, 2021 at 12:07AM FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

The FDA issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

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Black Ops Cold War Feb 26 patch notes: 2XP, Prop Hunt, and more - CharlieINTEL.com

1. Black Ops Cold War Feb 26 patch notes: 2XP, Prop Hunt, and more  CharlieINTEL.com
2. What's Up With These Huge Video Game Install Sizes? - IGN  IGN
3. Outbreak is the Call of Duty Zombies mode we need right now  PC Gamer
4. CoD Cold War Outbreak: best guns | The best loadout for zombies  VG247
5. Activision admits the complete Call of Duty experience no longer fits on an original PS4  The Verge
6. View Full Coverage on Google News

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February 27, 2021 at 12:08AM FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting

Following a positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization

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February 26, 2021 at 10:56PM cobas MPX

cobas MPX Test, for use on the cobas 6800/8800 Systems
Direct detection of Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA, and Hepatitis B Virus (HBV) DNA in human plasma
Simultaneous detection and discrimination of HIV RNA, HCV RNA, and HBV DNA in human donor plasma or serum specimens

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February 26, 2021 at 06:09PM cobas Zika

This test is intended for use to screen donor samples for Zika virus RNA in plasma samples from individual human donors, including donors of whole blood and blood components, and other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beating. Plasma from all donors should be screened as individual samples.

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February 26, 2021 at 06:04PM cobas WNV

cobas® WNV is indicated for qualitative in vitro nucleic acid screening test for the direct detection of West Nile Virus (WNV) RNA in human plasma.

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February 26, 2021 at 06:50PM 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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February 26, 2021 at 02:43PM Biologics Rules

Proposed & Final Rules specifically related to biologics are organized by biologics product area. Cross-Center and Office of the Commissioner Proposed and Final Rules are posted in the general FDA Rules section.

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Call of Duty Modern Warfare, Warzone, and Black Ops Cold are too big for the PS4 - Polygon

1. Call of Duty Modern Warfare, Warzone, and Black Ops Cold are too big for the PS4  Polygon
2. Activision warns a standard 500GB PS4 may no longer fit Call of Duty: Warzone, Black Ops Cold War and Modern Warfare  Eurogamer.net
3. Cold War Outbreak Easter Egg: Learn about the Dragon Relic Easter Egg  Republic TV
4. The best Warzone FARA 83 loadouts  Gamesradar
5. A 500GB PS4 May No Longer Be Able to Fit Call of Duty: Black Ops Cold War and Warzone - IGN  IGN
6. View Full Coverage on Google News

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Call of Duty Modern Warfare, Warzone, and Black Ops Cold are too big for the PS4 - Polygon

1. Call of Duty Modern Warfare, Warzone, and Black Ops Cold are too big for the PS4  Polygon
2. Best LC10 Black Ops Cold War loadout class: Attachments, setup, perks  Dexerto
3. Activision warns a standard 500GB PS4 may no longer fit Call of Duty: Warzone, Black Ops Cold War and Modern Warfare  Eurogamer.net
4. A 500GB PS4 May No Longer Be Able to Fit Call of Duty: Black Ops Cold War and Warzone - IGN  IGN
5. Zombies Outbreak: Is There An Easter Egg In The New Black Ops Cold War Mode?  DualShockers
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February 25, 2021 at 10:19PM Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine

Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine

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February 23, 2021 at 10:08PM Coronavirus (COVID-19) Update: February 23, 2021

Coronavirus (COVID-19) Update: February 23, 2021

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February 22, 2021 at 10:02PM Biological Approvals by Year

A collection of biological approval information organized by year and regulatory authorities.

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February 22, 2021 at 08:09PM BIMO/Team Biologics/Internet Surveillance/Other

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

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February 22, 2021 at 06:13PM Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

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February 22, 2021 at 05:31PM 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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February 22, 2021 at 04:17PM COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

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Fauci calls 500,000 coronavirus deaths 'terrible' - POLITICO

1. Fauci calls 500,000 coronavirus deaths 'terrible'  POLITICO
2. In Their Own Words: U.S. Covid-19 Death Toll Hits 500000 | NBC Nightly News  NBC News
3. U.S. not 'out of the woods' as nation nears 500,000 COVID-19 deaths  Yahoo News
4. Virus Outbreak: News and Analysis From Feb. 22, 2020  Bloomberg
5. The US is about to top 500,000 Covid-19 deaths. That's why it's critical to keep up safety measures, Fauci says  CNN
6. View Full Coverage on Google News

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Army of the Dead: Release Date Set for Zack Snyder's Netflix Zombie Movie - Collider

1. Army of the Dead: Release Date Set for Zack Snyder's Netflix Zombie Movie  Collider
2. ‘Army of the Dead’ New Look: Zack Snyder’s Zombie Outbreak Epic Hits Netflix May 21  Yahoo Entertainment
3. The Poster for Zack Snyder's Army of the Dead Releases the Zombie Cut  Gizmodo
4. Zack Snyder's 'Army of the Dead' Shambles to Netflix on May 21st! [Poster]  Bloody Disgusting
5. Army of the Dead Release Date & Poster Revealed by Netflix!  ComingSoon.net
6. View Full Coverage on Google News

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February 21, 2021 at 08:33PM Vaccine and Related Biological Product Guidances

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

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February 19, 2021 at 09:15PM Evaluation and Characterization of Neutralizing Antibodies against Viruses Relevant to Blood-derived Products

A description of Pei Zhang's research program and related publications.

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February 19, 2021 at 09:20PM BeneFIX

Product approval information is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease)

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February 19, 2021 at 08:03PM 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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February 19, 2021 at 07:38PM 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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February 18, 2021 at 10:58PM 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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February 18, 2021 at 07:44PM Importance of Influenza Vaccination for Health Care Personnel

Importance of Influenza Vaccination for Health Care Personnel

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February 18, 2021 at 07:20PM Influenza Virus Vaccine Composition and Lot Release

Influenza Virus Vaccine Composition and Lot Release

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February 18, 2021 at 06:28PM Zostavax (Herpes Zoster Vaccine) Questions and Answers

Zostavax is an FDA licensed vaccine that helps to reduce the risk of getting herpes zoster (shingles) in individuals 50 years of age and older. Answers are provided to common questions about Zostavax and Herpes Zoster.

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February 18, 2021 at 04:44PM Pentacel

For active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease caused by Haemophilus influenzae type b when administered to infants and children 6 weeks through 4 years of age (prior to fifth birthday).

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February 18, 2021 at 04:41PM Quadracel

Indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis. A single dose of Quadracel is approved for use in children 4 through 6 years of age as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series

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February 18, 2021 at 04:21PM Thimerosal in Vaccines Questions and Answers

Answers to commonly asked questions about Thimerosal in vaccines.

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February 17, 2021 at 10:26PM Standards Development for Regenerative Medicine Therapies

Section 3036 of the 21st Century Cures Act refers to the development of standards for regenerative medicine therapies, including products designated regenerative medicine advanced therapies.

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February 17, 2021 at 10:27PM 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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February 17, 2021 at 10:01PM ACAM2000 (Smallpox Vaccine) Questions and Answers

Questions about Smallpox and ACAM2000

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February 17, 2021 at 06:53PM Ticks and Lyme Disease: Symptoms, Treatment, and Prevention

Lyme disease is on the rise. How can you prevent it? What are the symptoms, and what should you do if you think you or your pet have it?

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February 16, 2021 at 08:58PM Emergency Use of an Investigational Drug or Biologic

Emergency Use of an Investigational Drug or Biologic - guidance

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February 17, 2021 at 02:03PM Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee

These are the Past Meeting Materials for the Cellular, Tissue and Gene Therapies Advisory Committee

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February 17, 2021 at 02:03PM 2021 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee

This is the main page for the CBER 2021 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee.

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February 17, 2021 at 02:02PM Cellular, Tissue, and Gene Therapies Advisory Committee April 15, 2021 Meeting Announcement - 04/15/2021 - 04/15/2021

This is the CBER Cellular, Tissue, and Gene Therapies Advisory Committee April 15, 2021 Meeting Announcement.

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The latest on the coronavirus pandemic and vaccines: Live updates - CNN

1. The latest on the coronavirus pandemic and vaccines: Live updates  CNN
2. New Zealand ends lockdown after deciding outbreak contained  Associated Press
3. Auckland lockdown to end despite three new cases of Covid-19  The Guardian
4. New Zealand Reports New Community Cases as Lockdown Call Looms  Bloomberg
5. New Zealand ponders extending lockdown as 2 new cases found  Associated Press
6. View Full Coverage on Google News

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Covid: Melbourne lockdown to end after quarantine outbreak controlled - BBC News

1. Covid: Melbourne lockdown to end after quarantine outbreak controlled  BBC News
2. Australia’s second-largest city comes out of 3rd lockdown  WBOY.com
3. Tennis crowds to be allowed back to Australian Open after Victoria lockdown lifts  The Guardian
4. Victoria's lockdown to lift at midnight but some restrictions remain in place  The Guardian
5. Australia politics live: Dan Andrews announces end of Victoria Covid lockdown at midnight in press conference update  The Guardian
6. View Full Coverage on Google News

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February 16, 2021 at 09:51PM Regulatory Submissions in Electronic Format for Biologic Products

FDA has started the transition to a more automated electronic review process for these submissions.

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February 16, 2021 at 08:58PM Vaccine Adverse Event Reporting System (VAERS) Questions and Answers

VAERS is a national vaccine safety surveillance program created as an outgrowth of the National Childhood Vaccine Injury Act of 1986 (NCVIA) and is administered by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC).

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February 16, 2021 at 08:43PM Flu Vaccines

Influenza, also known as the flu, is a contagious disease that is caused by influenza viruses. Influenza viruses infect the respiratory tract (nose, throat, and lungs) in humans. The flu is different from a cold, mainly because the symptoms and complications are more severe.

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February 16, 2021 at 08:31PM Trumenba (Serogroup B Meningococcal Vaccine) Questions and Answers

The FDA is announcing the approval of Trumenba, the first vaccine approved in the United States to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

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February 16, 2021 at 07:32PM Tissue Reference Group

This update includes recommendations for FY 2015 for the Tissue Reference Group.

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February 16, 2021 at 07:27PM Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting

Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting

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February 16, 2021 at 06:41PM 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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February 16, 2021 at 05:07PM Tissue and Tissue Product Questions and Answers

Tissue and Tissue Product Questions and Answers

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February 16, 2021 at 03:29PM Roster of the Cellular, Tissue and Gene Therapies Advisory Committee

This is the Roster of the Cellular, Tissue and Gene Therapies Advisory Committee.

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The FDA Has Issued A Warning About Cheeses Like Queso Fresco Due To A Listeria Outbreak That May Be Linked - Yahoo Lifestyle

1. The FDA Has Issued A Warning About Cheeses Like Queso Fresco Due To A Listeria Outbreak That May Be Linked  Yahoo Lifestyle
2. CDC Issues Warning About Cheeses Such As Queso Fresco Due To Listeria  WJZ
3. CDC Issues Warning for Cheeses Linked to Northeast Listeria Outbreak  NBC New York
4. The FDA Is Investigating A Listeria Outbreak That May Be Linked To Cheeses Like Queso Fresco  Delish.com
5. CDC investigating Listeria outbreak in four states  Medical Xpress
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The FDA Has Issued A Warning About Cheeses Like Queso Fresco Due To A Listeria Outbreak That May Be Linked - Yahoo Lifestyle

1. The FDA Has Issued A Warning About Cheeses Like Queso Fresco Due To A Listeria Outbreak That May Be Linked  Yahoo Lifestyle
2. CDC Issues Warning About Cheeses Such As Queso Fresco Due To Listeria  WJZ
3. CDC Issues Warning for Cheeses Linked to Northeast Listeria Outbreak  NBC New York
4. CDC investigating Listeria outbreak in four states  Medical Xpress
5. The FDA Is Investigating A Listeria Outbreak That May Be Linked To Cheeses Like Queso Fresco  Delish.com
6. View Full Coverage on Google News

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One down, one to go: Another winter storm could dump 5 more inches of snow on Dallas-Fort Worth - The Dallas Morning News

1. One down, one to go: Another winter storm could dump 5 more inches of snow on Dallas-Fort Worth  The Dallas Morning News
2. Texas winter storm leaves 2.5M without power amid frigid temperatures  Fox News
3. Historic Arctic outbreak brings dangerous cold, snow and ice to central and southern U.S.  The Washington Post
4. Winter storms not finished yet after Denton, metroplex get inches of snowfall  Denton Record Chronicle
5. Power emergency across Texas as snow, ice blanket southern Plains  FOX 29
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Guinea declares first Ebola outbreak since 2016, after confirming 7 new cases linked to a funeral - Business Insider

1. Guinea declares first Ebola outbreak since 2016, after confirming 7 new cases linked to a funeral  Business Insider
2. Guinea Declares Ebola Outbreak as Disease Returns to West Africa  Bloomberg Quicktake: Now
3. Guinea declares new Ebola epidemic, five years after West Africa’s deadliest outbreak  Washington Post
4. New Ebola outbreak declared in Guinea | TheHill  The Hill
5. WHO pledges urgent aid after Guinea health officials warn of new Ebola 'epidemic'  FRANCE 24 English
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CNN Exclusive: WHO Wuhan mission finds possible signs of wider original outbreak in 2019 - CNN

1. CNN Exclusive: WHO Wuhan mission finds possible signs of wider original outbreak in 2019  CNN
2. WHO investigator claims China refused to hand over key Covid information  The Guardian
3. China rips US over suggestion it withheld virus data | TheHill  The Hill
4. The WHO investigation into the coronavirus origin must be free of China’s meddling  Washington Post
5. W.H.O. Researcher on His Trip to China Seeking Virus Origins  The New York Times
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Novak Djokovic’s five-set battle at Australian Open started with fans and ended without them - The Washington Post

1. Novak Djokovic’s five-set battle at Australian Open started with fans and ended without them  The Washington Post
2. Australian city Melbourne begins 3rd lockdown due to cluster  The Associated Press
3. Australian Open Bans Spectators As State Enters 5-Day Lockdown  NPR
4. As the Australian Open plays on, Victoria officials order a ‘circuit breaker’ Covid lockdown.  The New York Times
5. Australian Open to Close Doors to Fans After New Covid Outbreak  The Wall Street Journal
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February 12, 2021 at 11:14PM Coronavirus (COVID-19) Update: February 12, 2021

Coronavirus (COVID-19) Update

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February 12, 2021 at 08:06PM Cord Blood Banking - Information for Consumers

Expecting a baby can be a very exciting time for soon-to-be-parents. It can also be very confusing, with many decisions to make. One choice prospective parents often face is whether to donate, bank or discard their baby's cord blood. Did you know that the Food and Drug Administration (FDA) regulates

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February 12, 2021 at 06:52PM Assessing the Mechanism of Immunotherapy for Allergy and Allergic Asthma: Effect of Viral Respiratory Infections on Pathogenesis and Clinical Course of Asthma and Allergy

A description of Ronald Rabin's research program and related publications.

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February 12, 2021 at 04:58PM PANZYGA

Indicated for 1.) Primary humoral immunodeficiency (PI) in patients 2 years of age and older
2.) Chronic immune thrombocytopenic purpura (ITP) in adults

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Australian city Melbourne begins 3rd lockdown due to cluster - Associated Press

1. Australian city Melbourne begins 3rd lockdown due to cluster  Associated Press
2. Covid: Victoria state to enter third lockdown after outbreak of UK variant  bbc.com
3. Daniel Andrews announces five-day 'circuit breaker' as Victoria goes into Covid lockdown  Guardian News
4. Melbourne steps up COVID tests as quarantine hotel cluster rises to 11 cases  Yahoo News
5. Australian Open Proceeds Even as Melbourne Enters Snap Lockdown  Bloomberg
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February 11, 2021 at 10:36PM Recently Issued Guidance Documents

This page lists Recently Issued CBER and Cross-Center Guidance Documents.

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February 11, 2021 at 10:36PM Blood Guidances

This page contains a listing of Blood Guidances guidances.

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February 11, 2021 at 10:36PM Investigational COVID-19 Convalescent Plasma

FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.


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February 11, 2021 at 09:47PM FDA Voices on Medical Products

FDA Voices on Medical Products

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February 11, 2021 at 07:38PM Blood Products Advisory Committee July 18-19, 2018 Meeting Announcement - 07/17/2018 - 07/18/2018

This is the Meeting Announcement for the July 18-19, 2018, Blood Products Advisory Committee (BPAC) Meeting.

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February 11, 2021 at 04:34PM Tissue Establishment Registration

Establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated solely under section 361 of the Public Health Service (PHS) Act are required to register with FDA pursuant to 21 CFR Part 1271. Also, provided information on when to register update regist

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February 10, 2021 at 07:42PM 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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February 10, 2021 at 05:42PM Health Fraud Scams

Learn how to spot health fraud and avoid it.

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February 10, 2021 at 02:50PM Meeting Materials, Vaccines and Related Biological Products Advisory Committee

These are the Meeting Materials for the Vaccines and Related Biological Products Advisory Committee

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February 10, 2021 at 02:49PM 2021 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

This is the main page for the CBER 2021 Meeting Materials, Vaccines and Related Biological Products Advisory Committee (VRBPAC).

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February 10, 2021 at 02:49PM Vaccines and Related Biological Products Advisory Committee February 26, 2021 Meeting Announcement - 02/26/2021 - 02/26/2021

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

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February 10, 2021 at 02:07PM Biologics Guidances

This page displays links to Biologics Guidance documents.

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February 09, 2021 at 09:49PM 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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February 09, 2021 at 09:47PM Human Cell and Tissue Establishment Registration (HCTERS) Public Query Application

Welcome to the Human Cell and Tissue Establishment Registration (HCTERS) Public Query application. You may use this application to review Human Cell and Tissue registration information for registered, inactive, and pre-registered firms.

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February 09, 2021 at 09:39PM COVID-19 Vaccine Safety Surveillance

This page describes the monitoring the safety of authorized COVID-19 vaccines through both passive and active safety surveillance systems.

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February 08, 2021 at 10:59PM Afluria, Afluria Southern Hemisphere

For active immunization of persons ages 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.

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February 08, 2021 at 10:43PM Afluria Quadrivalent, Afluria Quadrivalent Southern Hemisphere

For active immunization of persons ages 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.

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February 08, 2021 at 07:06PM Tissue Research

List of Tissue Research

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February 08, 2021 at 06:42PM Tissue & Advanced Therapies Research

This page is about Tissue & Advanced Therapies Research

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February 08, 2021 at 05:12PM Center for Biologics Evaluation and Research Patient Engagement Program

Patient input is a critical part of CBER’s understanding of diseases and conditions. Engaging with patients and listening to their perspectives on their diseases and treatments may help the center advance patient-focused medical product development.

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AstraZeneca Covid-19 Vaccine Weaker Against South Africa Strain - The Wall Street Journal

1. AstraZeneca Covid-19 Vaccine Weaker Against South Africa Strain  The Wall Street Journal
2. The latest on the coronavirus pandemic and vaccines: Live updates  CNN
3. Covid: Oxford jab offers less S Africa variant protection  BBC News
4. Just how effective is the Oxford coronavirus vaccine for the over-65s?  The Guardian
5. Virus Outbreak: News and Analysis From Jan. 7, 2021  Bloomberg
6. View Full Coverage on Google News

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DOH: Second case of U.K. COVID variant detected in Hawaii - Hawaii News Now

1. DOH: Second case of U.K. COVID variant detected in Hawaii  Hawaii News Now
2. Students, staff to quarantine days after California school reopens; outbreaks stoke tensions among state lawmakers. Latest COVID-19 updates.  USA TODAY
3. Drive-Thru Festival of Hope helps families in Chinatown on Oahu impacted by coronavirus  KHON2 News
4. State confirms 2nd case of COVID-19 variant from U.K. found in another Oahu resident with no history of travel  Honolulu Star-Advertiser
5. HAWAII VIRUS TRACKER - Feb. 6: 108 New COVID-19 Infections  Honolulu Civil Beat
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Major Arctic outbreak to bring bone-chilling air to Central U.S. - Washington Post

1. Major Arctic outbreak to bring bone-chilling air to Central U.S.  Washington Post
2. 13 On Your Side Forecast: Brutal Winter Days  13 ON YOUR SIDE
3. Several storms to chug across US, bringing snow, dangerous travel conditions  Fox News
4. Colder temperatures with occasional light snow this weekend  KETV NewsWatch 7
5. Arctic air may spread across United States, hit Massachusetts next week; ‘Brutally cold temperatures’ 25 to 3  MassLive.com
6. View Full Coverage on Google News

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February 06, 2021 at 01:49AM Coronavirus (COVID-19) Update: February 5, 2021

Coronavirus (COVID-19) Update

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February 05, 2021 at 01:25AM Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.’s COVID-19 Vaccine Candidate

The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc.

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February 05, 2021 at 01:18AM FDA In Brief: FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data

The FDA updates the emergency use authorization for COVID-19 convalescent plasma to reflect new analyzed data.

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February 05, 2021 at 12:56AM Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone, Intradermal Quadrivalent, Fluzone Quadrivalent Southern Hemisphere

For active immunization of persons 6 months of age and older for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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February 04, 2021 at 11:37PM CBER Reports

This page contains a summary of regulatory, research, and administrative accomplishments for the last 2 fiscal years and related reports.

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February 04, 2021 at 11:30PM Coronavirus (COVID-19) Update: FDA Continues Important Work to Support Medical Product Development to Address New Virus Variants

FDA Continues Important Work to Support Medical Product Development to Address New Virus Variants

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February 04, 2021 at 10:20PM Rare Disease Therapy Development and Access Remain Top FDA Priorities During COVID-19

FDA’s work to advance treatments for rare diseases and helping ensure continuity of care for people with rare diseases remain top priorities during COVID-19.

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February 04, 2021 at 08:36PM CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs

CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs

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February 04, 2021 at 06:44PM Partnering with the European Union and Global Regulators on COVID-19

The FDA and the European Commission (EC) and its European Medicines Agency (EMA) are collaborating on many scientific and regulatory fronts as part of our COVID-19 response.

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February 04, 2021 at 04:58PM 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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February 04, 2021 at 04:48PM Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN.

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February 03, 2021 at 08:45PM Consumer Updates

Science-based health and safety information you can trust.

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February 03, 2021 at 05:55PM 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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February 03, 2021 at 04:36PM Quick Guide to Web Resources

Quick Guide to Web Resources

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February 02, 2021 at 10:08PM Common Ingredients in U.S. Licensed Vaccines

Common ingredients found in vaccines that are commonly administered to healthy babies, children and adults are discussed to determine their safety and effectiveness.

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February 02, 2021 at 08:47PM Patient Listening Sessions

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

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February 02, 2021 at 03:25PM Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2021

This is the list of guidance topics CBER is considering for development during Calendar Year 2021.

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February 01, 2021 at 09:17PM Testing for Biotin Interference in In Vitro Diagnostic Devices

Testing for Biotin Interference in In Vitro Diagnostic Devices, Guidance for Industry, Final, CBER, Biologics

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U.S. House subcommittee to investigate Tyson, other meat companies - 4029tv

1. U.S. House subcommittee to investigate Tyson, other meat companies  4029tv
2. Clyburn targets OSHA, meatpacking companies with investigation of COVID-19 outbreaks  USA TODAY
3. U.S. House panel launches inquiry into COVID outbreaks at JBS, other meatpackers  Greeley Tribune
4. Meatpacking Companies, OSHA Face Investigation Over Coronavirus In Plants  NPR
5. House panel launches probe into meatpackers' coronavirus response  CNN
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February 01, 2021 at 03:19PM 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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Nguyen Phu Trong: Vietnam's 76-year-old leader gets rare third term - Yahoo News

1. Nguyen Phu Trong: Vietnam's 76-year-old leader gets rare third term  Yahoo News
2. Vietnam Party Chief Vows Renewed Push on Economic Growth  Bloomberg
3. Vietnam retains top leader, shuts Hanoi schools in COVID-19 battle  Yahoo News
4. Vietnam's Communist Party Cuts Short Key Congress Amid COVID-19 Outbreak  U.S. News & World Report
5. Nguyen Phu Trong, Vietnam's anti-corruption czar, crowned party chief again  Yahoo News
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WHO team in Wuhan visits disease control centers - The Associated Press

1. WHO team in Wuhan visits disease control centers  The Associated Press
2. Watching Wuhan: A year after COVID-19's initial outbreak  Face the Nation
3. World Health Organization team visits Wuhan market where first Covid-19 infections detected  NBC News
4. WHO teams visits Wuhan food market in search of virus clues  The Associated Press
5. WHO investigators visit Wuhan market in hunt for virus origin | TheHill  The Hill
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