Docket Number: FDA-2014-D-0609 Issued by: Guidance Issuing Office Office of Inspections and Investigations Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This […]

Docket Number: FDA-2018-D-2326 Issued by: Guidance Issuing Office Office of Inspections and Investigations Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This […]

Docket Number: FDA-2019-D-5743 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Office of Inspections and Investigations Office […]

Docket Number: FDA-2018-D-0787 Issued by: Guidance Issuing Office Office of Inspections and Investigations Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical […]

Delivery Method: UPS Overnight Product: DrugsFood & BeveragesMedical Devices Recipient: Recipient Name Spencer Baird Recipient Title Chief Executive Officer Inmar Supply Chain Solutions, LLC 1 W. […]

On This Page Date: August 2, 2024 Time: 9:00 AM – 6:00 PM ET What is an advisory committee? Advisory committees provide independent expert advice to […]

On This Page Date: April 9 – 10, 2025 Day1: Wed, Apr 9 8:30 AM – 5:00 PM ET Day2: Thu, Apr 10 8:30 AM – […]

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 […]

The Food and Drug Administration’s (FDA or Agency) Center for Biologics Evaluation and Research’s (CBER) and Center for Drug Evaluation and Research’s (CDER) are announcing the […]