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Last updated 1 day ago
Amneal Pharmaceutical LLC Issues a Nationwide Recall of Ropivacaine Hydrochloride Injection, USP 500mg/100mL, Due to the Potential Presence of Particulate Matter
1 day ago
Bridgewater, NJ, Amneal Pharmaceutical LLC, is recalling two lots of Ropivacaine Hydrochloride...
POSTPONED - Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act - 05/15/2025
3 days ago
Section 508 of PL 112-144 (FDASIA) requires FDA to obtain recommendations and...
Over-The-Counter Monograph Drug User Fee Program (OMUFA)
3 days ago
A user fee program for nonprescription (over-the-counter or OTC) monograph drugs would...
The Harvard Drug Group, LLC Issues Voluntary Nationwide Recall of Certain Rugby® Laboratories Brand Eye Drops Supplied by Velocity Pharma, LLC Due to Potential Risk of Eye Infections
3 days ago
La Vergne, TN, The Harvard Drug Group, LLC d/b/a Major® Pharmaceutical and...
List of Drug Master Files (DMFs)
4 days ago
The list is updated quarterly. Changes are made to the DMF activity...
Where and How to Dispose of Unused Medicines
4 days ago
The best way to dispose of your expired, unwanted, or unused medicines...
FDA Rationale for Breakpoints Recognition Decision: Piperacillin-Tazobactam and Pseudomonas aeruginosa
4 days ago
FDA Rationale for Breakpoints Recognition Decision: Piperacillin-Tazobactam and Pseudomonas aeruginosa
Nubratori, Inc. dba Nubratori Rx - 700513 - 01/22/2025
5 days ago
Compounding Pharmacy/Adulterated Drug Products
FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain
6 days ago
FDA continues to investigate counterfeit Ozempic (semaglutide) injection 1 milligram (mg) in...
Prescription Drug User Fee Amendments
6 days ago
The Prescription Drug User Fee Act (PDUFA) was created by Congress in...