Sep 4, 2025 | Drugs, FDA and USDA Regulatory Update, Medical Devices, Tobacco
September 04, 2025 FDA News Release Read on FDA Website The U.S. Food and Drug Administration today announced that it will release future complete response letters (CRLs) promptly after they are issued to sponsors. The agency also released today 89 previously...
Aug 27, 2025 | Drug and Device Corner, Drugs, Medical Devices
Generic Drug User Fee Amendments (GDUFA) 2026 user fees were published in the 30 July 2025 Federal Register (link below). User fees are due 1 October 2025. User Fee Type FY 2026 ANDADMF $ 358,247$ 102,584 Program Large SizeMedium SizeSmall Size $ 1,918,377$...
Aug 7, 2025 | Drugs, FDA and USDA Regulatory Update
August 7, 2025 FDA News Release Read on FDA Website The U.S. Food and Drug Administration today announced FDA PreCheck, a new program to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of...
Jul 23, 2025 | Drug and Device Corner, Drugs, Medical Devices
The FDA issued a notification on 9 July 2025 regarding an FDA Imports Review Exemption Change. The agency has rescinded the FDA review exemption that had previously been applicable to importation of certain low-value FDA regulated products. Henceforth all FDA...
Jul 14, 2025 | Drugs, Webinar
Overview of Regulatory Requirements for OTC Monograph Drugs Presented by Victoria Pankovich September 17, 2025, 1pm (eastern) If you are considering entering the OTC monograph drug space, the challenges of FDA regulatory requirements can be confusing. With a mixture...
Jul 10, 2025 | Drugs, FDA and USDA Regulatory Update
FDA News Release July 10, 2025 View on FDA Website The U.S. Food and Drug Administration (FDA) today published more than 200 decision letters, known as complete response letters (CRLs). The CRLs were issued in response to applications submitted to the FDA for approval...
