The FY 2022 GDUFA science and research report describes active research projects and outcomes organized in 13 scientific areas. In each area, we summarize the relevant […]

Image By: Robert M. Califf, M.D., Commissioner of Food and Drugs and Kaveeta P. Vasisht, M.D., PharmD, Associate Commissioner for Women’s Health and Director of the […]

Introduction This web page provides information related to upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective generic […]

Generic medications are just as safe and effective as their brand-name counterparts, and often cost less.  As 9 in 10 prescriptions filled are for generics, people […]

For Immediate Release: May 14, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Monday, […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Jonathan P. O’Dwyer Recipient Title President and CEO Seatex, LLC 445 Texas Highway 36Rosenberg, TX 77471United […]

Delivery Method: VIA EMAIL WITH READ RECEIPT Product: Drugs Recipient: Recipient Name Ms. Rachel C. Schwartz Recipient Title Director of Pharmacy Central Admixture Pharmacy Services, Inc. […]

Delivery Method: VIA EMAIL CONFIRMED DELIVERY Product: Drugs Recipient: Recipient Name Mr. Paul A. Schirmer Recipient Title Chief Executive Officer Westwood Laboratories LLC 710 S. Ayon […]

Delivery Method: UPS Product: Drugs Recipient: Recipient Name Dr. Samih Abouhalkah Recipient Title President Vintage Chemical Inc. 2007 Bremer Rd.Fort Wayne, IN 46803United States Issuing Office: […]