What’s New for Biologics
Fri Feb 27 2:08 pm
FDA | What's New: Vaccines
Drugs@FDA Data Files
Fri Feb 27 10:58 am
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
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Why Protecting Confidential Information is Key to the FDA’s "Gold Standard"
Thu Feb 26 12:14 pm
The FDA must maintain a delicate balance: being a model of openness regarding the scientific basis of its decisions, while safeguarding the proprietary secrets of the industries it regulates as well as personal data.
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Cleared 510(k) Submissions with Supporting Documents - 2026
Thu Feb 26 9:58 am
Questions about Blood
Wed Feb 25 5:41 pm
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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Biologics Electronic Reading Room (eFOIA)
Wed Feb 25 5:27 pm
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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Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause
Wed Feb 25 8:30 am
This is the draft guidance Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause
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Vaccines and Related Biological Products Advisory Committee March 12, 2026 Meeting Announcement - 03/12/2026
Wed Feb 25 8:00 am
On March 12, 2026, the Committee will meet in open session to discuss and make recommendations on the strain composition of influenza virus vaccines for use in United States during the 2026-2027 influenza season.
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Rare Diseases at FDA
Tue Feb 24 1:38 pm
The FDA works with many people and groups, such as patients, caregivers, and drug and device manufactures, to support rare disease product development.
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Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone, Intradermal Quadrivalent, Fluzone Quadrivalent Southern Hemisphere, Fluzone High-Dose Quadrivalent Southern Hemisphere
Tue Feb 24 1:24 pm
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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Dynamic Stem Cell Therapy - 712579 - 02/11/2026
Tue Feb 24 9:20 am
COMIRNATY
Mon Feb 23 11:37 am
COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID 19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
COMIRNATY is approved for use in individuals who are:
65 years of age and older, or
5 years through 64 years of age with
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COMIRNATY is approved for use in individuals who are:
65 years of age and older, or
5 years through 64 years of age with
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