January 31, 2024 at 01:45PM STRATAGRAFT

For the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns)

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January 31, 2024 at 07:07PM About CBER

The Center for Biologics Evaluation and Research (CBER) is one Center within the Food and Drug Administration, an Agency within the United States Government's Department of Health and Human Services

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January 30, 2024 at 11:19PM FDA Roundup: January 30, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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January 30, 2024 at 04:58PM CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19

CDER Scientific Reviews Supporting EUA for Therapeutic Products

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January 30, 2024 at 02:16PM 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

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January 30, 2024 at 02:08PM 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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January 29, 2024 at 11:57PM GAMMAGARD LIQUID

Product approval information is indicated for:
• Replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older.
• Maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN).

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January 29, 2024 at 02:42PM Cellular & Gene Therapy Guidances

This page contains a listing of cellular and gene therapy guidances.

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January 26, 2024 at 06:02PM Section 8100: Communication

This is the CBER SOPP Section 8100: Communication main page.

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January 26, 2024 at 02:00PM Conducting Remote Regulatory Assessments Questions and Answers

Conducting Remote Regulatory Assessments Questions and Answers Draft Guidance for Industry

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January 26, 2024 at 12:38PM 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 25, 2024 at 09:45PM ADYNOVATE

Product approval information is indicated for children and adults with hemophilia A (congenital factor VIII deficiency) for: (1) On-demand treatment and control of bleeding episodes; (2) Perioperative management; (3) Routine prophylaxis to reduce the frequency of bleeding episodes.

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January 25, 2024 at 08:53PM Vaccines and Related Biological Products Advisory Committee October 5, 2023 Meeting Announcement - 10/05/2023

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) October 5, 2023 announcement and meeting materials.

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January 24, 2024 at 04:47PM Cellular, Tissue, and Gene Therapies Advisory Committee October 31, 2023 Meeting Announcement - 10/31/2023

This is the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) October 31, 2023 meeting announcement and materials main page.

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January 23, 2024 at 10:13PM FDA Roundup: January 23, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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January 22, 2024 at 09:01PM Consumer Updates

Science-based health and safety information you can trust.

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New illnesses reported, products added in charcuterie meat recall - USA TODAY

1. New illnesses reported, products added in charcuterie meat recall  USA TODAY
2. Cases almost double as CDC expands warning of salmonella infections linked to recalled charcuterie meats  WQOW TV News 18
3. Salmonella cases linked to Costco charcuterie nearly doubled  4 News Now
4. Information about the salmonella outbreak involving meats sold at Costco and Sam’s Club  Miami Herald
5. Salmonella outbreak linked to samplers at NJ Costco, Sam's Club stores  New Jersey 101.5 FM

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New illnesses reported, products added in charcuterie meat recall - USA TODAY

1. New illnesses reported, products added in charcuterie meat recall  USA TODAY
2. Information about the salmonella outbreak involving meats sold at Costco and Sam’s Club  Miami Herald
3. Salmonella cases linked to Costco charcuterie nearly doubled  4 News Now
4. Cases almost double as CDC expands warning of salmonella infections linked to recalled charcuterie meats  WQOW TV News 18
5. Salmonella outbreak linked to samplers at NJ Costco, Sam's Club stores  New Jersey 101.5 FM

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CDC expanding tainted charcuterie meat probe affecting Costco, Sam's Club - Fox Business

1. CDC expanding tainted charcuterie meat probe affecting Costco, Sam's Club  Fox Business
2. CDC expanding salmonella warnings in Costco charcuterie  KREM 2 News
3. Urgent warning to Costco shoppers as salmonella outbreak linked to its Charcuterie meats  Daily Mail
4. CDC expands warning about charcuterie meat trays as salmonella cases double  East Idaho News
5. CDC issues warning over charcuterie meats  KFYR-TV

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CDC expanding tainted charcuterie meat probe affecting Costco, Sam's Club - Fox Business

1. CDC expanding tainted charcuterie meat probe affecting Costco, Sam's Club  Fox Business
2. Charcuterie sold at Costco and Sam's Club is being linked to a salmonella outbreak  NPR
3. CDC expands warning about charcuterie meat trays as salmonella cases double  KSL.com
4. CDC expanding salmonella warnings in Costco charcuterie  KREM 2 News
5. Urgent warning to Costco shoppers as salmonella outbreak linked to its Charcuterie meats  Daily Mail

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January 19, 2024 at 08:13PM Biomarker-driven Drug Development for Allergic Diseases and Asthma; Public Workshop - 02/22/2024

This public workshop is intended to be a forum for the exchange of information and perspectives among regulators and academic investigators on the use of biomarkers to monitor, predict efficacy, and evaluate responses to novel therapeutics for allergic diseases.

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Costco charcuterie meats linked to salmonella outbreak that has sickened dozens - NBC News

1. Costco charcuterie meats linked to salmonella outbreak that has sickened dozens  NBC News
2. Cases almost double as CDC expands warning of salmonella infections linked to recalled charcuterie meats  CNN
3. CDC expands warning about charcuterie meat trays as salmonella cases double  The Associated Press
4. CDC recalls more charcuterie meat products after 47 people fall ill  KVLY
5. Salmonella outbreak: CDC expands warning on charcuterie meats  WTOL

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Costco charcuterie meats linked to salmonella outbreak that has sickened dozens - NBC News

1. Costco charcuterie meats linked to salmonella outbreak that has sickened dozens  NBC News
2. Cases almost double as CDC expands warning of salmonella infections linked to recalled charcuterie meats  CNN
3. Salmonella outbreak: CDC expands warning on charcuterie meats  WTOL
4. CDC expands warning about charcuterie meat trays as salmonella cases double  The Associated Press
5. CDC tracking growing salmonella outbreak linked to charcuterie meats  Hawaii News Now

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Cases almost double as CDC expands warning of salmonella infections linked to recalled charcuterie meats - CNN

1. Cases almost double as CDC expands warning of salmonella infections linked to recalled charcuterie meats  CNN
2. CDC expands warning about charcuterie meat trays as salmonella cases double  The Associated Press
3. Salmonella outbreak: CDC expands warning on charcuterie meats  WTOL
4. CDC tracking growing salmonella outbreak linked to charcuterie meats  Hawaii News Now
5. CDC recalls more charcuterie meat products after 47 people fall ill  First Alert 4

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January 18, 2024 at 09:49PM Biologics Electronic Reading Room (eFOIA)

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 18, 2024 at 12:29AM Industry Frequently Asked Questions

Frequently asked questions and the associated answers sorted by topic area

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January 17, 2024 at 11:24PM Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act

Procedural

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January 17, 2024 at 07:25PM Medical Device User Fee Small Business Qualification and Certification

This guidance describes the process for how a business may request qualification and certification as a small business.

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January 17, 2024 at 02:03PM 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 16, 2024 at 09:27PM FDA Roundup: January 16, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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January 16, 2024 at 05:45PM HYQVIA

Indicated for the treatment of Primary Immunodeficiency (PI) in adults.

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January 16, 2024 at 01:40PM BIMO/Team Biologics/Internet Surveillance/Other

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

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National Weather Service issues warning of ‘bitter cold’ across US - The Hill

1. National Weather Service issues warning of ‘bitter cold’ across US  The Hill
2. Arctic Outbreak to Send Temperatures Below Zero Across Much of Nation  AccuWeather
3. Protect your home amid upcoming January Arctic blast  KFDX - Texomashomepage.com
4. Team coverage: Preparing you for Arctic blast -- from the roads to your homes  KHOU 11
5. What's Behind the 'Arctic Blast' Plunging into the U.S.?  Scientific American

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Arctic Air Mass Will Bring Freezing Temperatures This Weekend - The New York Times

1. Arctic Air Mass Will Bring Freezing Temperatures This Weekend  The New York Times
2. Arctic Outbreak to Send Temperatures Below Zero Across Much of Nation  AccuWeather
3. Protect your home amid upcoming January Arctic blast  KFDX - Texomashomepage.com
4. Arctic assault comes with another snow risk late in the weekend  KOLR10 & Fox49
5. What's Behind the 'Arctic Blast' Plunging into the U.S.?  Scientific American

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National Weather Service issues warning of ‘bitter cold’ across US - The Hill

1. National Weather Service issues warning of ‘bitter cold’ across US  The Hill
2. Arctic Outbreak to Send Temperatures Below Zero Across Much of Nation  AccuWeather
3. What's Behind the 'Arctic Blast' Plunging into the U.S.?  Scientific American
4. Arctic assault comes with another snow risk late in the weekend  KOLR10 & Fox49
5. Safety Preparation Tips for Upcoming Arctic Blast | News | hometownstations.com  Your News Now

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Arctic blast: Record-breaking cold weather forecast for many states - BBC.com

1. Arctic blast: Record-breaking cold weather forecast for many states  BBC.com
2. Arctic Outbreak to Send Temperatures Below Zero Across Much of Nation  AccuWeather
3. What's Behind the 'Arctic Blast' Plunging into the U.S.?  Scientific American
4. Preparing your home ahead of the arctic blast next week  FOX19
5. Safety Preparation Tips for Upcoming Arctic Blast | News | hometownstations.com  Your News Now

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January 12, 2024 at 02:55PM Vaccines

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

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January 12, 2024 at 02:51PM Questions about Vaccines

Information on general and specific vaccines

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January 11, 2024 at 02:16PM Kimera Labs, Inc. - 649343 - 09/01/2023

Investigational Device Exemptions (IDE)

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Cold arctic blast arrives Friday: prepare for high winds, blowing snow and extreme cold - Fox 12 Oregon

1. Cold arctic blast arrives Friday: prepare for high winds, blowing snow and extreme cold  Fox 12 Oregon
2. Arctic Cold Outbreak Could Smash Records | Weather.com  The Weather Channel
3. Expect sub-zero temps, snow beginning Saturday in central Ohio  The Columbus Dispatch
4. Polar vortex set to send arctic blast deep into US later this week, resulting in lowest temps this winter so far  New York Post
5. Indiana braces for arctic blast following weekend low-pressure system  WISH TV Indianapolis, IN

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Arctic blast to bring 'dangerously cold' temperatures - NBC News

1. Arctic blast to bring 'dangerously cold' temperatures  NBC News
2. Arctic Cold Outbreak Could Smash Records | Weather.com  The Weather Channel
3. Polar vortex set to send arctic blast deep into US later this week, resulting in lowest temps this winter so far  New York Post
4. Expect sub-zero temps, snow beginning Saturday in central Ohio  The Columbus Dispatch
5. Cold arctic blast arrives Friday: prepare for high winds, blowing snow and extreme cold  Fox 12 Oregon

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Cold arctic blast arrives Friday: prepare for high winds, blowing snow and extreme cold - Fox 12 Oregon

1. Cold arctic blast arrives Friday: prepare for high winds, blowing snow and extreme cold  Fox 12 Oregon
2. Arctic Cold Outbreak Could Smash Records | Weather.com  The Weather Channel
3. Expect sub-zero temps, snow beginning Saturday in central Ohio  The Columbus Dispatch
4. Polar vortex set to send arctic blast deep into US later this week, resulting in lowest temps this winter so far  New York Post
5. Indiana braces for arctic blast following weekend low-pressure system  WISH TV Indianapolis, IN

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January 10, 2024 at 04:46PM IXCHIQ

For the prevention of disease caused by chikungunya virus (CHIKV) in
individuals 18 years of age and older who are at high risk of exposure to CHIKV.

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Storms envelop much of US, bringing heavy snow, rains, tornadoes - Reuters

1. Storms envelop much of US, bringing heavy snow, rains, tornadoes  Reuters
2. Monster storm system sparks deadly tornado outbreak in Gulf Coast and Southeast  NBC News
3. Winter storm slams central and eastern US  CNN
4. 3 Killed as Storms and Likely Tornadoes Tear Through Southeastern U.S.  The New York Times
5. Winter Storm Finn, Severe Storms Updates | Weather.com  The Weather Channel

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Winter storm: Tornadoes, flooding rain threaten East Coast - ABC News

1. Winter storm: Tornadoes, flooding rain threaten East Coast  ABC News
2. Monster storm system sparks deadly tornado outbreak in Gulf Coast and Southeast  NBC News
3. Winter storm slams central and eastern US  CNN
4. 3 Killed as Storms and Likely Tornadoes Tear Through Southeastern U.S.  The New York Times
5. Tornadoes, blizzard conditions and high wind warnings impact millions in winter storms across U.S.: Full coverage  Yahoo News

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3 Killed as Storms and Likely Tornadoes Tear Through Southeastern U.S. - The New York Times

1. 3 Killed as Storms and Likely Tornadoes Tear Through Southeastern U.S.  The New York Times
2. Live Updates: Winter Storm Finn, Severe Storms | Weather.com  The Weather Channel
3. Monster storm system sparks deadly tornado outbreak in Gulf Coast and Southeast  NBC News
4. Deadly storms across the US deliver tornadoes, snow and flooding  BBC.com
5. NYC braces for major storm that will bring 60mph winds and coastal flooding to the Big Apple - as NJ declares  Daily Mail

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January 09, 2024 at 09:36PM Section 8400: Marketing Applications

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

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January 09, 2024 at 08:59PM Staff Fellow/Visiting Associate – Pharmacology/Toxicology Reviewer

The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP), Office of Pharmacology/Toxicology (OPT) is recruiting to fill multiple Staff Fellow/Visiting Associate positions to serve as Pharmacology/Toxicology Reviewers.

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January 09, 2024 at 07:04PM FDA Approves Many New Drugs in 2023 that Will Benefit Patients and Consumers

FDA’s Center for Drug Evaluation and Research (CDER) approved a wide range of therapies in 2023 that will help patients and consumers live better and possibly longer lives.

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January 09, 2024 at 03:20PM MiMedx Group, Inc. - 662942 - 12/20/2023

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

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January 05, 2024 at 06:26PM RECOTHROM

Product approval information is indicated for An aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pedi

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January 05, 2024 at 05:44PM 2023 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

This is the main page for the CBER 2023 Meeting Materials, Vaccines and Related Biological Products Advisory Committee (VRBPAC).

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January 05, 2024 at 12:00AM 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 04, 2024 at 11:18PM POSTPONED- Vaccines and Related Biological Products Advisory Committee February 15, 2022 Meeting Announcement - 02/15/2022

This the CBER Vaccines and Related Biological Products Advisory Committee February 15, 2022 Meeting Announcement

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January 04, 2024 at 08:36PM CBER Vaccine ICSR Implementation

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

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January 04, 2024 at 07:46PM Getting Started with ICSR Submission to FDA’s electronic Vaccine Adverse Event Reporting System (eVAERS)

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

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January 03, 2024 at 09:46PM Vaccines and Related Biological Products Advisory Committee June 7, 2022 Meeting Announcement - 06/07/2022

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee June 7, 2022 Meeting Announcement and meeting materials.

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January 03, 2024 at 04:07PM CASGEVY

CASGEVY indicated for the treatment of sickle cell disease (SCD) in patients 12 years and older with recurrent vaso occlusive crises (VOCs).

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December 29, 2023 at 07:49PM Roster of the Vaccines and Related Biological Products Advisory Committee

This is the Roster of the Vaccines and Related Biological Products Advisory Committee

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January 02, 2024 at 06:40PM Vaccines and Related Biological Products Advisory Committee June 28, 2022 Meeting Announcement - 06/28/2022

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee June 28, 2022 Meeting Announcement.

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