Apotex Inc. – 714137 – 10/31/2025

Delivery Method: VIA UPS Reference #: 320-26-12 Product: Drugs Recipient: Recipient Name Mr. Allan Oberman Recipient Title President & Chief Executive Officer Apotex Inc. 150 Signet DriveToronto ON M9L 1T9Canada Issuing Office: Center for Drug Evaluation and...

BsUFA IV: Fiscal Years 2028-2032

On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022. This new law includes the second reauthorization of the Biosimilar User Fee Act (BsUFA) that provides FDA with the necessary resources to maintain a predictable and...

Quit Kit, LLC – Online Advisory Letter

 Online Advisory Letter Reference #715029September 10, 2025Quit Kit, LLC3304 Selwyn Farms Lane, Unit 3Charlotte, NC 28209info@tryquitkit.comPhone # 718-974-8797Dear Matthew von Boecklin:This letter is to advise you that the U.S. Food and Drug Administration (FDA)...