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Generic Drug Research Collaboration Opportunities
The Office of Generic Drugs implements the GDUFA Regulatory Science Research Program by collaborating through grants or contracts.Applicator Recall: Integra LifeSciences Removes Extended Tip Applicator Due to Potential Sterility and Endotoxin Concerns
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A.S.K. Foods, LLC of Palmyra, PA is recalling select 32 oz. containers of Publix Rice & Pigeon Peas because it contains undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume this product.Public Meeting on the Reauthorization of the Prescription Drug User Fee Act (PDUFA) – 07/14/2025
On July 14, 2025, the Food and Drug Administration (FDA or Agency) held a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2028 through 2032.Oasis Medical, Inc. – 707198 – 07/15/2025
CGMP/Finished Pharmaceuticals/AdulteratedE2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
