Thursday, October 31, 2024

October 31, 2024 at 07:50PM Artificial Intelligence for Drug Development

FDA recognizes the increased use of AI throughout the drug development process and across a range of therapeutic areas. Learn more.

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Wednesday, October 30, 2024

October 30, 2024 at 04:06PM Vaccines and Related Biological Products Advisory Committee October 10, 2024 Meeting Announcement - 10/10/2024

This is the main page for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) October 10, 2024 Meeting announcement and meeting materials.

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October 25, 2024 at 12:06AM CBER Rare Disease Program 

Description of CBER's Rare Disease Program, including a description of the program, selected activities, examples of collaborations internal and external to CBER, and frequently asked questions.

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October 22, 2024 at 11:18PM VISTASEAL

Fibrin Sealant lead page - FIBRIN SEALANT (Human) is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. FIBRIN SEALANT (Human)

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October 22, 2024 at 03:20PM Pinnacle Transplant Technologies, LLC - 646783 - 10/01/2024

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

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October 22, 2024 at 03:20PM Namita A. Goyal, M.D. - 677324 - 10/10/2024

Clinical Investigator

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Monday, October 21, 2024

October 21, 2024 at 07:58PM 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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October 21, 2024 at 02:59PM Chemical Analysis for Biocompatibility Assessment of Medical Devices

This draft guidance document provides the FDA’s recommendations on analytical chemistry testing to assess the biocompatibility of medical devices.

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Friday, October 18, 2024

October 18, 2024 at 02:23PM FDA Rare Disease Innovation Hub

FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients.

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Thursday, October 17, 2024

October 17, 2024 at 02:37PM Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method

This is the draft guidance Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method

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October 16, 2024 at 03:50PM eSubmitter Application History

History of all updates to the application software in reverse chronological order by version number

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Tuesday, October 15, 2024

October 15, 2024 at 03:20PM Hemarus LLC - 688656 - 10/08/2024

CGMP/Blood & Blood Components/Adulterated

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October 15, 2024 at 03:01PM It’s a Good Time to Get Your Flu Vaccine

Getting vaccinated in the fall can lower your chances of getting the flu. Haven’t had your flu shot yet? It’s not too late. Every flu season is different. Your best defense against the flu is to get a vaccine every year.

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Friday, October 11, 2024

October 11, 2024 at 10:15PM FDA Roundup: October 11, 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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October 11, 2024 at 06:40PM COMIRNATY

COMIRNATY is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.

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October 11, 2024 at 04:58PM Section 8400: Marketing Applications

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

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Thursday, October 10, 2024

October 10, 2024 at 11:36PM 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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October 10, 2024 at 07:55PM 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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Friday, October 4, 2024

October 04, 2024 at 10:00PM FDA Roundup: October 4, 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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October 04, 2024 at 08:35PM Influenza Virus Vaccine, H5N1 (for National Stockpile)

List of Injectable Vaccines - Influenza Virus Vaccine, H5N1 (for National Stockpile)

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October 04, 2024 at 04:30PM Meeting 1: Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases - 09/20/2024

FDA CBER Patient Listening Meeting: Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases

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October 04, 2024 at 02:31PM 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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Thursday, October 3, 2024

October 03, 2024 at 04:20PM COVID-19 Vaccines

FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines.

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Wednesday, October 2, 2024

October 02, 2024 at 02:21PM Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee

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

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October 02, 2024 at 02:20PM 2024 Meeting Materials, Cellular, Tissue, and Gene Therapies Advisory Committee

This is the main page for the 2024 Meeting Materials for the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC).

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October 02, 2024 at 02:19PM Cellular, Tissue, and Gene Therapies Advisory Committee November 21, 2024 Meeting Announcement - 11/21/2024

This is the main page for the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) November 21, 2024 announcement and meeting materials.

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Tuesday, October 1, 2024

October 01, 2024 at 01:02PM Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration

The term "complementary and alternative medicine" (CAM) encompasses a wide array of health care practices, products, and therapies that are distinct from practices, products, and therapies used in "conventional" or "allopathic" medicine.

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