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Last updated about 2 hours ago
FDA In Brief: 2016 annual summary report of sales and distribution data for antimicrobial drugs intended for use in food-producing animals
about 2 hours ago
FDA’s annual report summarizing 2016 sales and distribution estimates for antimicrobial drugs...
FDA In Brief: FDA provides guidance on improving the agency’s interactions with product developers to make the drug development process more informed and efficient
about 2 hours ago
FDA announces two new guidances to support enhanced communication with drug developers...
FDA Approves Prescription Nasal Spray to Reverse Opioid Overdose
about 4 hours ago
The U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride...
FDA Approves First Over-the-Counter Naloxone Nasal Spray
about 4 hours ago
The U.S. Food and Drug Administration approved the first naloxone nasal spray...
Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a Glass Particle
about 5 hours ago
Foster City, Calif., September 20, 2024 - Gilead Sciences, Inc. (Nasdaq: GILD)...
President's Emergency Plan for AIDS Relief (PEPFAR)
about 5 hours ago
Presidential Emergency Plan for AIDS Relief content
FDA/Center for Research on Complex Generics (CRCG) Workshop on Visionary Standards: Advancing Science and Regulation in Generic Ophthalmic Products - 11/19/2025
about 6 hours ago
This 2-day hybrid workshop will explore the evolving landscape of generic ophthalmic...
FDA Information Session on Generic Drug Research Needs & Opportunities for FY 2026 - 01/21/2026
about 24 hours ago
FDA is hosting a virtual Information Session on Generic Drug Research Needs...
Resources for Biomarker Requestors
1 day ago
Information and resources for requestors about FDA’s Biomarker Qualification Program
Emerging Drug Safety Technology Meetings (EDSTM)
1 day ago
CDER has established a meeting program called the Emerging Drug Safety Technology...
Clinical Decision Support Software
2 days ago
This guidance clarifies the scope of FDA’s oversight of clinical decision support...
FDA Roundup: July 23, 2024
2 days ago
The U.S. Food and Drug Administration is providing an at-a-glance summary of...