Online Advisory Letter Reference # 716717   December 4, 2025                         Bodynplant 96 Mowat AveToronto, ON M6K 3M1, CA  RE: Vaginal-Uterine […]

Image CaptionMiracle cure! Truly amazing! Works in minutes! Guaranteed! These are just a few of the false claims made by fraudulent health care products that should […]

Clinical Outcome Assessments (COAs) and Available FDA Pathways to Seek Advice: Additional Considerations: CLINICAL OUTCOME ASSESSMENTS (COAs) AND AVAILABLE FDA PATHWAYS: What is a COA and […]

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

[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 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 […]

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 […]