[1/21/2026] The U.S. Food and Drug Administration announced that it will begin accepting applications on February 1, 2026 for the PreCheck Pilot Program. This program will strengthen the domestic pharmaceutical supply chain by increasing […]

Office of Study Integrity and Surveillance (OSIS) Workshop 2022 – Day 1 – Welcome & Session 1   Welcome by Office of Study Integrity and Surveillance […]

SBIA: Welcome to the CDER Small Business and Industry Assistance (SBIA) Chronicles Podcast Series Today’s topic: The ABCs of Product-Specific Guidances, otherwise knowns as PSGs. PSGs […]

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 26-HFD-45-01-01 Product: Drugs Recipient: Recipient Name Dayan B. Goodenowe, Ph.D. Recipient Title CEO Prodrome Sciences […]

Delivery Method: Via Email Reference #: 320-26-28 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Darren J. Birkelbach Recipient Title Chief Executive Officer Integrity Partners Group […]

Docket Number: FDA-2025-D-2275 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA, […]