January 31, 2022 at 11:31PM cobas TaqScreen MPX Test, version 2.0

Product approval information for
•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.

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January 31, 2022 at 08:20PM 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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January 31, 2022 at 07:49PM Cellular, Tissue and Gene Therapies Advisory Committee October 12, 2017 Meeting Announcement - 10/12/2017

This is the CBER Cellular, Tissue and Gene Therapies Advisory Committee October 12, 2017 Meeting Announcement.

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January 31, 2022 at 05:56PM 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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January 31, 2022 at 05:55PM Licensed Biological Products with Supporting Documents

Licensed biological products with supporting documents is arranged alphabetically by the proper name of the product(s). Information is provided for original product approvals, new indications, and the current package insert.

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January 31, 2022 at 05:53PM SPIKEVAX

COVID19 Vaccine, mRNA

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January 31, 2022 at 05:32PM Coronavirus (COVID-19) Update: FDA Takes Key Action by Approving Second COVID-19 Vaccine

The FDA approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older.

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January 31, 2022 at 04:55PM Spikevax and Moderna COVID-19 Vaccine

Information about the Moderna COVID-19 Vaccine and Spikevax

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Sweeping bill on inquiry into US Covid response sees bipartisan support - The Guardian

1. Sweeping bill on inquiry into US Covid response sees bipartisan support  The Guardian
2. New U.S. Task Force Prepares for Next Outbreak  Bloomberg
3. First Thing: inquiry into US Covid response has bipartisan support  The Guardian
4. View Full Coverage on Google News

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January 29, 2022 at 03:41AM Laboratory Information Bulletins

Laboratory Information Bulletins available to the public

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January 28, 2022 at 07:09PM 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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January 28, 2022 at 06:52PM Vaccines and Related Biological Products Advisory Committee March 3, 2022 Meeting Announcement - 03/03/2022

This is the CBER Vaccines and Related Biological Products Advisory Committee March 3, 2022 Meeting Announcement.

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January 28, 2022 at 06:45PM 2022 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

This is the main page for the CBER 2022 Meeting Materials, Vaccines and Related Biological Products Advisory Committee (VRBPAC).

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January 28, 2022 at 02:51PM Principles of Premarket Pathways for Combination Products

Final guidance for industry and FDA staff: Principles of Premarket Pathways for Combination Products

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January 27, 2022 at 01:30PM YESCARTA (axicabtagene ciloleucel)

YESCARTA is a treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

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January 27, 2022 at 07:08PM Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories

To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities

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January 27, 2022 at 05:09PM Questions about Blood

FDA is responsible for ensuring the safety of the Nation's blood supply. While a blood supply with zero risk of transmitting infectious disease may not be possible, there are several measures taken by FDA to protect and enhance the safety of blood products.

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January 26, 2022 at 08:49PM Premarket Approvals (PMAs) and Humanitarian Device Exemptions (HDEs)

List of Premarket Approvals (PMAs) and Humanitarian Device Exemptions (HDEs)

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January 26, 2022 at 08:06PM Premarket Approval (PMA) for CBER-Regulated Products

Center for Biologics Evaluation and Research (CBER) regulates medical devices related to licensed blood and cellular products while applying appropriate medical device laws and regulations.

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Australian Aid Ship Docks in Tonga With a Covid Outbreak - The New York Times

1. Australian Aid Ship Docks in Tonga With a Covid Outbreak  The New York Times
2. A Covid-stricken Australian aid ship is heading for virus-free Tonga  CNN
3. COVID-free Tonga cautiously receives aid from ship with virus outbreak  CBS News
4. More than 20 Australian sailors aiding Tonga test COVID-positive  Al Jazeera English
5. 23 Australians on ship delivering aid to Tonga have COVID-19  Honolulu Star-Advertiser
6. View Full Coverage on Google News

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A Covid-stricken Australian aid ship is heading for virus-free Tonga - CNN

1. A Covid-stricken Australian aid ship is heading for virus-free Tonga  CNN
2. Coronavirus Outbreak Is Reported on Aid Ship Bound for Tonga  The New York Times
3. More than 20 Australian sailors aiding Tonga test COVID-positive  Al Jazeera English
4. 23 Australians on ship delivering aid to Tonga have COVID-19  Honolulu Star-Advertiser
5. 23 Australians on ship delivering aid to Tonga have virus  Hawaii News Now
6. View Full Coverage on Google News

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January 25, 2022 at 02:48PM Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

From Patient Engagement Advisory Committee recommendations, this draft guidance describes engagement of patient advisors in design and conduct of device trials.

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January 25, 2022 at 02:47PM Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation

Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation

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COVID cases reported on Australian aid vessel sailing to virus-free Tonga - Reuters

1. COVID cases reported on Australian aid vessel sailing to virus-free Tonga  Reuters
2. 23 Australians on ship delivering aid to Tonga have virus  NPR
3. Covid outbreak strikes Australian aid ship bound for virus-free Tonga  The Guardian
4. View Full Coverage on Google News

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January 24, 2022 at 10:01PM Biologics Guidances

This page displays links to Biologics Guidance documents.

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January 24, 2022 at 09:48PM Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2022

This is the list of guidance topics CBER is considering for development during Calendar Year 2022

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January 24, 2022 at 07:51PM Donating Blood Questions and Answers

Suitability to donate blood depends on the donation not being injurious to the donor and the donated blood not being unnecessarily hazardous to the recipient. Questions and answers for individuals interested in donating blood.

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January 24, 2022 at 07:38PM Cleared 510(k) Submissions with Supporting Documents

Listing of cleared 510(k) submissions with supporting documents. Information is reflected as of the clearance date.

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New Zealand adds new COVID restrictions as omicron spreads - NPR

1. New Zealand adds new COVID restrictions as omicron spreads  NPR
2. New Zealand to Tighten Covid Settings as Omicron Arrives  Bloomberg
3. New Zealand to tighten curbs in case of Omicron outbreak  Reuters
4. New Zealand says it won't use lockdowns when omicron spreads  Associated Press
5. New Zealand will not impose lockdown when omicron hits  NPR

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New Zealand adds new COVID restrictions as omicron spreads - Yahoo News

1. New Zealand adds new COVID restrictions as omicron spreads  Yahoo News
2. New Zealand to Tighten Covid Settings as Omicron Arrives  Bloomberg
3. New Zealand to tighten curbs in case of Omicron outbreak  Reuters
4. New Zealand says it won't use lockdowns when omicron spreads  Associated Press
5. New Zealand will not impose lockdown when omicron hits  NPR
6. View Full Coverage on Google News

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Adele surprises fans in Las Vegas with video call after postponing concerts - CNN

1. Adele surprises fans in Las Vegas with video call after postponing concerts  CNN
2. Adele Postpones Las Vegas Residency After COVID Outbreak  Inside Edition
3. Adele clashed with Las Vegas venue over 60-person choir: report  Page Six
4. Adele FaceTimes Upset Fans in Las Vegas for Residency Show  TMZ
5. Production of Adele's Las Vegas shows sparked 'explosive arguments' between singer and set designer  Daily Mail
6. View Full Coverage on Google News

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Adele surprises fans in Las Vegas with video call after postponing concerts - CNN

1. Adele surprises fans in Las Vegas with video call after postponing concerts  CNN
2. Adele Postpones Las Vegas Residency After COVID Outbreak  Inside Edition
3. Adele clashed with Las Vegas venue over 60-person choir: report  Page Six
4. Caesars posts Q&A for Adele fans looking for answers after residency postponed  KTNV Las Vegas
5. Adele FaceTimes Upset Fans in Las Vegas for Residency Show  TMZ

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Adele FaceTimes With Forgiving Fans After Las Vegas Residency Postponement - Variety

1. Adele FaceTimes With Forgiving Fans After Las Vegas Residency Postponement  Variety
2. Adele Postpones Las Vegas Residency After COVID Outbreak  Inside Edition
3. Adele clashed with Las Vegas venue over 60-person choir: report  Page Six
4. Caesars posts Q&A for Adele fans looking for answers after residency postponed  KTNV Las Vegas
5. Adele FaceTimes Upset Fans in Las Vegas for Residency Show  TMZ
6. View Full Coverage on Google News

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Adele fans say they don't believe her story that COVID killed Las Vegas shows - Daily Mail

1. Adele fans say they don't believe her story that COVID killed Las Vegas shows  Daily Mail
2. Adele thanks fans for support after last-minute postponement of Las Vegas residency  The Independent
3. Adele Postpones Las Vegas Residency After COVID Outbreak  Inside Edition
4. Adele announces all dates of Las Vegas Strip residency to be rescheduled  FOX5 Las Vegas
5. Tearful Adele FACETIMES stunned fans and flogs her expensive merchandise after cancelling residency  Daily Mail
6. View Full Coverage on Google News

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Adele fans say they don't believe her story that COVID killed Las Vegas shows - Daily Mail

1. Adele fans say they don't believe her story that COVID killed Las Vegas shows  Daily Mail
2. Adele Postpones Las Vegas Residency After COVID Outbreak  Inside Edition
3. Adele tearfully postpones Las Vegas residency 1 day before kickoff due to COVID-related issues  Yahoo Entertainment
4. Adele announces all dates of Las Vegas Strip residency to be rescheduled  FOX5 Las Vegas
5. Adele TEARS UP in Update on Her Las Vegas Residency  Entertainment Tonight

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January 21, 2022 at 10:47PM FDA Public Meeting: Identification of Concepts and Terminology for Multi-Component Biomarkers - 03/23/2022

The FDA Center for Drug Evaluation and Research and the FDA Biomarker Working Group will convene a virtual workshop on March 23-24, 1-3 PM (EST) entitled “Identification of Concepts and Terminology for Multi-Component Biomarkers”. The workshop is intended to develop multi-component biomarker concepts and terminology to identify areas of conceptual

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January 21, 2022 at 09:35PM 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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January 21, 2022 at 09:09PM OraQuick ADVANCE Rapid HIV-1/2 Antibody Test

Added labeling claim for the detection of HIV-2 antibodies in oral fluid and a change in the name of the device to OraQuick ADVANCE Rapid HIV-1/2 Antibody Test

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January 21, 2022 at 08:56PM Collecting and Providing 702(b) Portions of FDA Official Samples

Collecting and Providing 702(b) Portions of FDA Official Samples - Questions and Answers

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January 20, 2022 at 04:25PM Blood Grouping and Phenotyping Reagents

Blood Grouping and Phenotyping Reagents Main Page

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January 19, 2022 at 07:47PM Patient Engagement & Regenerative Medicine: An FDA CBER Workshop for Patient Advocates - 05/06/2021

FDA is hosting a patient workshop on May 6, 2021. This workshop will bring together patients, caregivers, advocates, and other important stakeholders to discuss ways for patients and their advocates to work with FDA to help advance regenerative medicine for rare and genetic diseases.

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New Zealand will not impose lockdown when omicron hits - NPR

1. New Zealand will not impose lockdown when omicron hits  NPR
2. New Zealand to tighten curbs if there's an Omicron outbreak  Reuters
3. New Zealand says it won’t use lockdowns when omicron spreads  KNWA
4. As Omicron rages around the world, Ardern deploys an old tactic - delay  The Guardian
5. New Zealand rules out lockdowns as it prepares for Omicron outbreak  Reuters
6. View Full Coverage on Google News

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New Zealand rules out lockdowns as it prepares for Omicron outbreak - Reuters

1. New Zealand rules out lockdowns as it prepares for Omicron outbreak  Reuters
2. New Zealand will not impose lockdown when omicron hits  NPR
3. New Zealand says it won’t use lockdowns when omicron spreads  WSYR
4. New Zealand to tighten curbs if there's an Omicron outbreak  Reuters
5. As Omicron rages around the world, Ardern deploys an old tactic - delay  The Guardian
6. View Full Coverage on Google News

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January 19, 2022 at 05:54PM Blood Products Advisory Committee November 4, 2021 Meeting Announcement - 11/04/2021

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

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COVID-infected hamsters in pet shop trigger animal cull in Hong Kong - Ars Technica

1. COVID-infected hamsters in pet shop trigger animal cull in Hong Kong  Ars Technica
2. Hong Kong to kill 2,000 animals after hamsters get COVID-19  Associated Press
3. Hong Kong to cull 2000 hamsters after COVID-19 outbreak  Reuters
4. Radio Station WHMI 93.5 FM — Livingston County Michigan News, Weather, Traffic, Sports, School Updates, and the Best Classic Hit  WHMI
5. Hong Kong Says Hamsters May Have Infected a Pet Shop Worker With COVID-19. Now They All Must Die  TIME

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Hong Kong to cull 2000 hamsters after COVID-19 outbreak - Reuters

1. Hong Kong to cull 2000 hamsters after COVID-19 outbreak  Reuters
2. Hong Kong to cull thousands of hamsters as covid risk  The Washington Post
3. Hong Kong to kill 2,000 animals after several hamsters test positive for COVID-19  Fox News
4. Radio Station WHMI 93.5 FM — Livingston County Michigan News, Weather, Traffic, Sports, School Updates, and the Best Classic Hit  WHMI
5. Hong Kong to kill 2,000 animals after hamsters get COVID-19  WHIO Radio
6. View Full Coverage on Google News

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Australia reports record COVID-19 deaths | TheHill - The Hill

1. Australia reports record COVID-19 deaths | TheHill  The Hill
2. Australia reports record COVID-19 deaths, hospitals under pressure  Fox News
3. Australia suffers deadliest day of pandemic as Omicron drives up hospital cases  Reuters
4. Covid: Australia suffers deadliest day of pandemic fuelled by Omicron outbreak  The Independent
5. View Full Coverage on Google News

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Hong Kong to cull thousands of hamsters as covid risk - The Washington Post

1. Hong Kong to cull thousands of hamsters as covid risk  The Washington Post
2. Hong Kong to kill 2,000 animals after several hamsters test positive for COVID-19  Fox News
3. Hong Kong to cull 2000 hamsters after COVID-19 outbreak  Reuters
4. Hong Kong to kill 2,000 animals after hamsters get COVID-19  Associated Press
5. 2,000 Pets Including Hamsters and Chinchillas to Be Killed to Curb COVID Spread  Newsweek
6. View Full Coverage on Google News

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January 18, 2022 at 03:31PM Substantially Equivalent 510(k) Device Information

Listing of 510(k) submissions

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January 18, 2022 at 03:29PM Approved Blood Products

Products that are regulated as Biologics License Applications (BLAs), New Drug Applications (NDAS), Premarket Approvals (PMAs), and 510(k)s.

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January 18, 2022 at 03:27PM Industry (Biologics)

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

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January 18, 2022 at 03:06PM Premarket Notification 510(k) Process for CBER-Regulated Products

CBER regulates medical devices related to licensed blood and cellular products while applying appropriate medical device laws and regulations.

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January 18, 2022 at 04:15AM Identification of Concepts and Terminology for Multi-Component Biomarkers Workshop - 03/23/2020

A productive discussion on the development of a conceptual, hierarchical & specific set of terminology needs in the biomarker domain.

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US Surgeon General warns 'next few weeks will be tough' as Omicron spreads - New York Post

1. US Surgeon General warns 'next few weeks will be tough' as Omicron spreads  New York Post
2. Omicron not peaking nationally yet, surgeon general says; Djokovic leaves Australia after losing appeal: COVID-19 updates  USA TODAY
3. Virus Outbreak: News and Analysis From Jan 17  Bloomberg
4. US Surgeon General Warns That Omicron Has Not Yet Peaked  The New York Times
5. Omicron wave of COVID has not yet peaked: U.S. surgeon general  New York Daily News

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January 14, 2022 at 08:33PM Clinical Investigator Inspection List L-P

Contains names, addresses, and other information gathered from inspections of clinical investigators (L-P) who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).

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January 14, 2022 at 08:33PM Clinical Investigator Inspection List E-K

Contains names, addresses, and other information gathered from inspections of clinical investigators (E-K) who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).

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January 14, 2022 at 08:32PM Clinical Investigator Inspection List A-D

Contains names, addresses, and other information gathered from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).

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January 11, 2022 at 08:40PM 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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January 14, 2022 at 03:48PM Many Important Drugs Approved in 2021 as COVID-19 Pandemic Continues

CDER approved a wide variety of safe and effective new drug therapies in 2021 despite challenges brought on by the ongoing COVID-19 pandemic.

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January 14, 2022 at 02:32AM 2022_01 Test Article FT 01

2022_01 Test Article some long description some long description.

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January 12, 2022 at 08:21PM How do I request a Patient Listening Session?

Learn about how to request a Patient Listening Session with the FDA to share your experiences and perspectives.

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'Zero-Covid' China fights to contain Omicron as restrictions tighten in major city - CNN

1. 'Zero-Covid' China fights to contain Omicron as restrictions tighten in major city  CNN
2. China locks down another city as Omicron spreads ahead of Beijing Olympics  CBS News
3. Chinese cities tighten COVID-19 curbs as Tianjin battles Omicron outbreak  Reuters
4. Testing Underway For Chinese City Of 14 million Under Zero Covid Strategy  NBC News
5. China's Tianjin orders more testing of 14 million residents  ABC News
6. View Full Coverage on Google News

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January 11, 2022 at 08:35PM Acceptance Review for De Novo Classification Requests

This guidance discusses De Novo acceptance policies and procedures, Refuse to Accept principles, and the Acceptance Checklist for De Novo Requests.

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January 11, 2022 at 07:28PM Exceptions and Alternative Procedures Approved Under 21 CFR 640.120

Title 21 Code of Federal Regulations 640.120(a) - The Director, Center for Biologics Evaluation and Research, may approve an exception or alternative procedures to any requirement in subchapter F (Biologics) of Chapter I (Parts 600 - 680) of title 21 of the Code of Federal Regulations regarding bloo

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January 11, 2022 at 05:45PM Safety & Availability (Biologics)

Important information about the safety and availability of biological products.

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January 10, 2022 at 09:57PM 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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January 10, 2022 at 09:47PM How to Report Product Problems and Complaints to the FDA

If you use a product regulated by the U.S. Food and Drug Administration and have an unexpected reaction or other problem, the FDA wants to hear from you. Learn how to report problems.

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January 10, 2022 at 05:57PM Avances para salvar vidas con sangre

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

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January 10, 2022 at 04:51PM Advances in Saving Lives with Blood

An FDA official in the Office of Blood Research and Review discusses promising technologies involving blood and blood products, from extending the life of blood products to using DNA technology to better match donors and recipients.

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January 10, 2022 at 03:16PM Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act

This guidance clarifies who should notify, what information to include, and how to notify FDA of shortages, during or in advance of a public health emergency



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E3 2022 Cancels Its In-Person Event - Dark Horizons

1. E3 2022 Cancels Its In-Person Event  Dark Horizons
2. E3 2022 To Be Online Only Event Once Again After Latest Covid Outbreak  TalkEsport - TE
3. MWC 2022 will be an in-person event despite Omicron scare  XDA Developers
4. E3 should never be in-person again  PC Gamer
5. With E3 2022 going virtual, Star Wars Celebration may unravel again  Dork Side of the Force
6. View Full Coverage on Google News

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January 07, 2022 at 11:03PM 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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January 07, 2022 at 09:45PM 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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January 07, 2022 at 09:43PM BEXSERO

Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

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January 07, 2022 at 08:25PM Vaccines and Related Biological Products Advisory Committee November 8, 2019 Meeting Announcement - 11/08/2019 - 11/08/2019

This is the CBER Vaccines and Related Biological Products Advisory Committee November 8, 2019 Meeting Announcement.

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January 07, 2022 at 08:16PM Vaccines and Related Biological Products Advisory Committee March 6 - 7, 2019 Meeting Announcement - 03/06/2019 - 03/07/2019

This is the CBER Vaccines and Related Biological Products Advisory Committee March 6 - 7, 2019 Meeting Announcement.

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January 07, 2022 at 05:57PM Biologics Electronic Reading Room (eFOI)

The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site.

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January 07, 2022 at 02:59PM Coronavirus (COVID-19) Update: FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months

The FDA amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.

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China's Henan adds COVID curbs as cases rise, Xian official apologises - Reuters

1. China's Henan adds COVID curbs as cases rise, Xian official apologises  Reuters
2. Xi'an Is China's Biggest Covid Challenge Since Wuhan  The New York Times
3. Xi'an lockdown brings heartbreak and dysfunction as political pressure to contain outbreak grows  CNN
4. Anger at Xi’an Lockdown Spreads in China  The Wall Street Journal
5. China Sees Covid Cases Across Country, Even After Xi'an's Drop  Bloomberg
6. View Full Coverage on Google News

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January 06, 2022 at 09:01PM Allergenic Products Advisory Committee September 13, 2019 Meeting Announcement - 09/13/2019 - 09/13/2019

This is the main page for the Allergenic Products Advisory Committee September 13, 2019 Meeting Announcement.

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January 06, 2022 at 08:22PM Vaccines and Related Biological Products Advisory Committee October 9, 2019 Meeting Announcement - 10/09/2019 - 10/09/2019

This is the CBER Vaccines and Related Biological Products Advisory Committee October 9, 2019 Meeting Announcement.

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China’s Henan imposes new restrictions as COVID cases spike: Live - Al Jazeera English

1. China’s Henan imposes new restrictions as COVID cases spike: Live  Al Jazeera English
2. Xi'an lockdown brings heartbreak and dysfunction as political pressure to contain outbreak grows  CNN
3. Tales of anguish emerge from China's locked-down Xian, as hospital staffers are fired over woman's treatment  The Washington Post
4. China's Henan imposes more COVID curbs as cases spike, though numbers small  Reuters
5. Chinese residents reportedly trading goods for food as world’s toughest lockdown continues  New York Post

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Xi'an lockdown brings heartbreak and dysfunction as political pressure to contain outbreak grows - CNN

1. Xi'an lockdown brings heartbreak and dysfunction as political pressure to contain outbreak grows  CNN
2. Tales of anguish emerge from China's locked-down Xian, as hospital staffers are fired over woman's treatment  The Washington Post
3. Residents of Xi'an, China, react to COVID lockdowns with outrage and humor  NPR
4. China's Henan imposes more COVID curbs as cases spike, though numbers small  Reuters
5. China’s Henan imposes new restrictions as COVID cases spike: Live  Al Jazeera English
6. View Full Coverage on Google News

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Stephen Colbert Has a Backup Plan for Parents in the Pandemic - The New York Times

1. Stephen Colbert Has a Backup Plan for Parents in the Pandemic  The New York Times
2. Florida Will Beat Covid By Testing Less | Drivers Still Stranded In Snow On I-95  The Late Show with Stephen Colbert
3. Late night hosts gape at the I-95 snow-in, mock 'dumb' COVID comments  The Week Magazine
4. Stephen Colbert Says He Won't Do 'The Late Show' Remotely Amid Omicron Outbreak: "Corona Is Dealing With Me Now"  Decider
5. Tonight On The Late Show Stephen Colbert Talks About The Holiday Omicron Surge  Deadline
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Kazakhstan's government resigns as fuel protests rage - CNN

1. Kazakhstan's government resigns as fuel protests rage  CNN
2. Kazakhstan Declares State of Emergency as Protests Over Fuel Prices Spread  The New York Times
3. Kazakhstan declares state of emergency amid unrest  Reuters
4. Kazakhstan protests: government resigns amid rare outbreak of unrest  The Guardian
5. What to know about the Kazakhstan fuel protests  The Washington Post

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January 04, 2022 at 04:31PM International Activities

CBER’s international activities can be categorized in the following functional areas: regulatory harmonization, regulatory capacity building, information sharing, international standards setting, and collaborative research.

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Maryland elected officials step in to support Baltimore keeping schools open in face of rising parental clamor - Baltimore Sun

1. Maryland elected officials step in to support Baltimore keeping schools open in face of rising parental clamor  Baltimore Sun
2. ‘It’s Chaos’ as Schools Confront Omicron  The New York Times
3. Despite omicron, most schools are staying open after the holidays  NPR
4. Baltimore City Schools Push To Keep Classrooms Open Despite Omicron Surge, More Baltimore County Schools Go Virtual  CBS Baltimore
5. How R.I. schools are handling another round of COVID-19 outbreaks  The Boston Globe
6. View Full Coverage on Google News

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January 03, 2022 at 03:34PM Global Unique Device Identification Database (GUDID)

Provides information necessary for submitting data to the Global Unique Device Identification Database (GUDID). Primarily intended for device labelers.

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January 03, 2022 at 03:31PM Coronavirus (COVID-19) Update: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine

The FDA amended the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to take several actions that will expand the use of the vaccine in certain populations.

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January 03, 2022 at 02:15PM Charter of the Vaccines and Related Biological Products Advisory Committee

This is the Charter of the Vaccines and Related Biological Products Advisory Committee.

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Defense Secretary Austin says he has tested positive for Covid-19 - CNN

1. Defense Secretary Austin says he has tested positive for Covid-19  CNN
2. Biden Defense Secretary Lloyd Austin tests positive for COVID-19  Fox News
3. Defense secretary tests positive for Covid, says his symptoms are mild  NBC News
4. Virus Outbreak: News and Analysis From Jan 3  Bloomberg
5. Pentagon Chief Austin Says He Has Tested Positive for COVID  NBC Chicago

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Pentagon chief Austin tests positive for Covid-19 - POLITICO

1. Pentagon chief Austin tests positive for Covid-19  POLITICO
2. Defense Secretary Austin says he has tested positive for Covid-19  CNN
3. Virus Outbreak: News and Analysis From Jan 3  Bloomberg
4. Biden Defense Secretary Lloyd Austin tests positive for COVID-19  Fox News
5. U.S. Defense Secretary Austin tests positive for Covid-19, mild symptoms  CNBC
6. View Full Coverage on Google News

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January 02, 2022 at 10:31PM FDA Voices on Medical Products

FDA Voices on Medical Products

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January 02, 2022 at 10:26PM FDA Voices on Policy

FDA Voices on Policy

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January 02, 2022 at 09:34PM 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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The Covid-19 case surge is altering daily life across the US. Things will likely get worse, experts warn - CNN

1. The Covid-19 case surge is altering daily life across the US. Things will likely get worse, experts warn  CNN
2. Virus Outbreak: News and Analysis From Jan 2  Bloomberg
3. New York State reports another record day of 85,000+ positive COVID cases Saturday  13WHAM-TV
4. New York state reports over 85,000 positive COVID cases  Spectrum News NY1
5. New York Shatters Daily Covid Record With 85476 New Cases  Bloomberg

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The Covid-19 case surge is altering daily life across the US. Things will likely get worse, experts warn - CNN

1. The Covid-19 case surge is altering daily life across the US. Things will likely get worse, experts warn  CNN
2. Virus Outbreak: News and Analysis From Jan. 1  Bloomberg
3. NY COVID latest: Saturday, January 1, 2022  WPIX 11 New York
4. NY Trumps Case Record by 9K, Reports Over 85,000 New Positives on New Year's Day  NBC New York
5. New York state COVID rate hits new high at New Year's start  WKRC TV Cincinnati
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