Image By: Richard Pazdur, MD, Director, Oncology Center of Excellence (OCE), and Rea Blakey, Associate Director for External Outreach and Engagement, OCE  If you’ve ever heard […]

Committee’s Official Designation Peripheral and Central Nervous System Drugs Advisory Committee Authority The Peripheral and Central Nervous System Drugs Advisory Committee (the Committee) is established under […]

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, […]

Facilities may request a certificate of pharmaceutical product or CGMP declaration using the CDER export certification and tracking system (CDEReCATS). CDEReCATS offers several benefits, including a possible […]

On This Page Date: June 3 – 5, 2024 Day1: Mon, Jun 3 9:00 AM – 6:00 PM ET Day2: Tue, Jun 4 9:00 AM – […]

For Immediate Release: May 31, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

Docket Number: FDA-2004-D-0241 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance provides recommendations to sponsors […]

Reference #: NDA 212122 Product: Drugs Recipient: Recipient Name Inna Kissen, Ph.D. Recipient Title Senior Director, Promotional Regulatory Affairs AstraZeneca Pharmaceuticals LP 1800 Concord PikeWilmington, DE […]

Product: Drugs Recipient: Recipient Name Pascal Soriot Recipient Title Executive Director and Chief Executive Officer AstraZeneca Pharmaceuticals LP 1800 Concord PikeWilmington, DE 19850United States Issuing Office: […]