Export Regulations and Guidance Documents The Federal Food Drug and Cosmetics Act and Code of Federal Regulations (CFR) requirements are applicable to human drug exports for […]

14th Annual Sentinel Initiative Public Workshop COVID-19; Drug Regulatory Process; Drug Development; Drug Safety No 0 6 Tip-Offs to Rip-Offs: Don’t Fall for Health Fraud Scams […]

On This Page Date: June 17 – 18, 2024 Day1: Mon, Jun 17 12:30 PM – 5:30 PM ET Day2: Tue, Jun 18 10:00 AM – […]

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

ACTIONS BY MONTH Oct-23 Nov-23 Dec-23 Jan-24 Feb-24 Mar-24 Apr-24 May-24 Jun-24 Jul-24 Aug-24 Sep-24 FY-2024 Approvals 57 51 53 56 52 48       […]

Docket Number: FDA-2024-D-1032 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA […]

For Immediate Release: May 03, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

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

Listen Dr. Roach: Welcome to “Q&A with FDA,” where we aim to answer some of the most frequently asked questions that we’ve received from the public. […]