Spotlight Events & Announcements Get Started with Your Submission The Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program accepts submissions for qualification of […]
The FY 2021 GDUFA Science and Research report provides detailed results for 13 areas of focus, each including a summary of research activities, research highlights, comprehensive […]
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. […]
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