This page provides drug and nonvaccine biological product manufacturers, distributors, packers, outsourcing facilities, and other interested parties with information about FDA Adverse Event Reporting System (FAERS) electronic submissions and instructions on how to electronically submit postmarketing
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Join us for the 2025 Advancing Generic Drug Development Workshop! FDA experts will demonstrate the FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program’s transformative impact on generic drug development, regulation, and approval.PDUFA Performance Reports
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Tropicale Foods of Ontario, CA is recalling certain Helados Mexico and La Michoacana products with specific best by dates, as detailed below because these products contain undeclared milk.TBC Distribution Corporate Recalls Lucky Foods Brand Cinnamon Powder Because of Possible Health Risk
TBC Distribution Corporate of Brooklyn, NY is recalling Lucky Foods brand Cinnamon Powder 40g, best before date 15.09.2027 because it has the potential to be contaminated with elevated levels of lead. ShortPrescription Drug User Fee Amendments
The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment
CENTER VALLEY, Pa., (October 31, 2025) – Olympus Corporation has announced a voluntary, global medical device corrective action to provide further clarification on the safe and effective use of bronchoscopes with laser therapy, argon plasma coagulation or high-frequency cauterization equipment durin