On This Page Date: November 20, 2024 Time: 9:00 AM – 12:30 PM ET Location: Event Location FDA HeadquartersFDA headquarters in White Oak, MD 10903 New […]

Information on mandatory reporting: Applicable Regulations You can search the FDA’s CFR Title 21 Database for the latest regulations. The links below will take you directly […]

Regulatory harmonization represents a process where regulatory authorities align technical requirements for the development and marketing of pharmaceutical products. Harmonization of regulatory requirements has many benefits […]

FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs. One of […]

On This Page Date: October 29, 2024 Time: 10:00 AM – 3:30 PM ET The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the […]

Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of […]

On This Page Date: December 4 – 5, 2024 Day1: Wed, Dec 4 8:30 AM – 5:30 PM ET Day2: Thu, Dec 5 8:30 AM – […]

Fundamental to the mission of the U.S. Food and Drug Administration is to engage patients and caregivers – to understand their unique perspectives and experiences and […]

Docket Number: FDA-2021-D-1031 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Veterinary Medicine FDA is […]