Thursday, February 26, 2026

2026-02-26T17:14:37Z Why Protecting Confidential Information is Key to the FDA’s "Gold Standard"

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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Wednesday, February 25, 2026

2026-02-25T22:41:06Z 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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2026-02-24T18:24:42Z 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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2026-02-24T14:20:07Z Dynamic Stem Cell Therapy - 712579 - 02/11/2026

Unapproved New Drugs/Unlicensed Biological Product Violations

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Monday, February 23, 2026

February 23, 2026 at 05:15PM Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause

This is the draft guidance Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known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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February 23, 2026 at 02:59PM Recalls (Biologics)

Biologic recalls are listed by year. Recalls are a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action.

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Sunday, February 22, 2026

February 22, 2026 at 08:40PM Rare Diseases at FDA

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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Friday, February 20, 2026

February 20, 2026 at 07:12PM eSubmitter Application History

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

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February 19, 2026 at 05:07PM Sperm Bank, Inc. dba Fertility Center of California - 694273 - 02/14/2025

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

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February 17, 2026 at 06:52PM BK251296- PUREGRAFT SYNC Adipose Filtration System

The Puregraft SYNC System is indicated for use in the harvesting, filtering, and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring.

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February 17, 2026 at 06:40PM Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

This guidance clarifies how FDA evaluates RWD to determine whether they are of sufficient quality for generating RWE for medical devices.

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February 13, 2026 at 07:48PM FDA Grand Rounds – Adeno-associated Virus-mediated Gene Therapy: Advances, Immune Challenges, and Research Innovations - 02/19/2026

Adeno-associated Virus-mediated Gene Therapy: Advances, Immune Challenges, and Research Innovations

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February 13, 2026 at 03:37PM Consumer Updates

Science-based health and safety information you can trust.

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Monday, February 9, 2026

February 10, 2026 at 12:38AM Commissioner's National Priority Voucher (CNPV) Pilot Program

FDA Commissioner's National Priority Voucher Program. The Commissioner's National Priority Voucher Program offers an unprecedented opportunity to reduce drug and biologic review times from 10-12 months to just 1-2 months.

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