February 28, 2023 at 03:40PM Measles, Mumps and Rubella Virus Vaccine Live

Product approval information for the Measles, Mumps, and Rubella Virus Vaccine, Live also known as M-M-R II.

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February 28, 2023 at 01:28PM KINRIX

Changes to your package insert to the Dosage and Administration section regarding visual inspection by the user for cracked vials or syringes prior to administration of the vaccine and non-use of product should those conditions exist.

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February 22, 2023 at 07:35PM 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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February 22, 2023 at 07:26PM Patient Listening Session Summaries

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

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February 21, 2023 at 11:06PM Adacel

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed

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February 21, 2023 at 07:46PM 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 21, 2023 at 05:07PM Jobs at the Center for Biologics Evaluation and Research (CBER)

CBER has unique opportunities for individuals with backgrounds in science or administration to fill positions involved in the regulation and research of blood, vaccines and therapeutics.

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February 17, 2023 at 10:11PM Information for Practitioners - FDA’s Regulatory Oversight of Regenerative Medicine Products - 11/17/2022

The FDA’s Center for Biologics Evaluation and Research (CBER) is hosting a public webinar on November 17, 2022, at 11:00 am.

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February 17, 2023 at 08:12PM Highlighting Major Issues Critical to FDA Across Our Diverse Agency After One Year Back

This week marks my one-year anniversary as the 25th Commissioner for Food and Drugs. I have been proud to represent the U.S. Food and Drug Administration and its talented and hard-working staff in these extraordinary times.

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February 16, 2023 at 03:43PM Executive Order 13944 List of Essential Medicines, Medical Countermeasures, and Critical Inputs

In consultation with other federal partners, FDA has developed a list of drug and biological product essential medicines, drug, biological product, and device medical countermeasures, and critical inputs, as required by Executive Order 13944. FDA welcomes public comment on this list.

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February 16, 2023 at 02:54PM 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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February 14, 2023 at 10:55PM FAQs: What happens to EUAs when a public health emergency ends?

Answers to frequently asked questions about what happens to Emergency Use Authorizations (EUAs), and medical products available under EUA, when a public health emergency ends.

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February 14, 2023 at 02:24AM Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone, Intradermal Quadrivalent, Fluzone Quadrivalent Southern Hemisphere, Fluzone High-Dose 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 13, 2023 at 10:45PM Moderna COVID-19 Vaccines

Information about Spikevax, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine, Bivalent. Updated COVID-19 vaccine boosters are now FDA-authorized.

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February 13, 2023 at 09:52PM Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products - 04/27/2023

Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual public listening meeting to solicit input on methods and approaches (e.g., use of real-world evidence (RWE), registries) for capturing post approval safety and efficacy data for cell and gene therapy products.

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February 13, 2023 at 09:08PM FDALabel: Full-Text Search of Drug Product Labeling

FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 140,000 labeling documents for FDA-approved drug products, including human and animal prescription and over-the-counter drugs, biological products, and medical devices.

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February 13, 2023 at 08:01PM VAXCHORA

VAXCHORA is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1.

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February 13, 2023 at 02:50PM Vaccine Safety & Availability

Vaccine Safety & Availability

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Amid cholera outbreak, health fears grow in quake-hit Syria - Al Jazeera English

1. Amid cholera outbreak, health fears grow in quake-hit Syria  Al Jazeera English
2. International community has failed Syrian earthquake victims, UN aid chief says  BBC News
3. After quake, Syrian schools silent as teachers, students perish  Yahoo News
4. Syria quake aid held up by hardline group, U.N. says  Reuters
5. Turkey-Syria Earthquake: Rescuers pull survivors from ruins five days after quake | Latest | WION  WION
6. View Full Coverage on Google News

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Syria quake aid held up by hardline group, U.N. says - Reuters.com

1. Syria quake aid held up by hardline group, U.N. says  Reuters.com
2. After quake, Syrian schools silent as teachers, students perish  Yahoo News
3. International community has failed Syrian earthquake victims, UN aid chief says  BBC News
4. Amid cholera outbreak, health fears grow in quake-hit Syria  Al Jazeera English
5. Turkey-Syria Earthquake: Rescuers pull survivors from ruins five days after quake | Latest | WION  WION

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Syria quake aid held up by hardline group, U.N. says - Reuters.com

1. Syria quake aid held up by hardline group, U.N. says  Reuters.com
2. Turkey-Syria Earthquake: Rescuers pull survivors from ruins five days after quake | Latest | WION  WION
3. Amid cholera outbreak, health fears grow in quake-hit Syria  Al Jazeera English
4. EU's Syria envoy says bloc is not shirking earthquake aid  Reuters.com
5. "Friend & Family" India to step up assistance to Syria, says Ambassador Dr Bassam Alkhatib  WION
6. View Full Coverage on Google News

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February 09, 2023 at 09:57PM Blood Grouping and Phenotyping Reagents

Blood Grouping and Phenotyping Reagents Main Page listed in alphabetical order by manufacturer, then by product

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February 09, 2023 at 07:24PM 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 08, 2023 at 11:25PM HIV Home Test Kits

Information and Links related to HIV Testing questions and answers are also provided.

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February 08, 2023 at 10:04PM 2009 H1N1 (Swine) Flu Virus (Biologics)

CBER's Vaccine and Blood Teams are working to facilitate the availability of safe and effective vaccines and ensuring that the blood supply is not affected by the H1N1 Flu Virus.

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February 07, 2023 at 11:23PM 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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February 07, 2023 at 08:53PM Gardasil

Product approval information for Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant also known as Gardasil.

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February 07, 2023 at 08:45PM Drugs@FDA Data Files

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

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February 07, 2023 at 12:35AM Pandemic Influenza Information

Pandemic influenza (flu) is a significant global public health threat. Preparedness has been recognized as a critical local, national and worldwide priority

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February 07, 2023 at 12:08AM Questions about Vaccines

Information on general and specific vaccines

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February 06, 2023 at 11:59PM Tissue & Tissue Products

CBER regulates human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient is regulated as a human cell, tissue, and cellular and tissue-based product or HCT/P.

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February 06, 2023 at 08:45PM Cellular & Gene Therapy Guidances

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

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February 06, 2023 at 02:32PM Immune Globulins

Lists of immune globulins fractionated plasma products blood.

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Eye drops recalled after 55 reports of bacterial infection, 1 death in 12 states - GMA

1. Eye drops recalled after 55 reports of bacterial infection, 1 death in 12 states  GMA
2. Eye drop manufacturer issues recall amid CDC investigation of infections, death  CNN
3. Eye drops recalled after US drug-resistant bacteria outbreak  The Seattle Times
4. Manufacturer recalls eye drops after possible link to bacterial infections  NPR
5. Artificial tears product sold in Utah linked to blindness, death  St George News
6. View Full Coverage on Google News

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February 03, 2023 at 08:55PM Workshops, Meetings & Conferences (Biologics)

Information on CBER sponsored or co-sponsored meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties.

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February 03, 2023 at 05:59PM 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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February 01, 2023 at 09:18PM Administrative Guidances

This page lists Administrative Guidance documents.

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February 01, 2023 at 05:05PM Patient Listening Session Summaries

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

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