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 The agency has rescinded the FDA review exemption that had previously been applicable to importation of certain low-value FDA regulated products.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...
Jun 24, 2025 | Drug and Device Corner, Drugs, Medical Devices
The FDA has released two proposed administrative orders for requesting minor dosage form changes to certain OTC monograph drugs. These administrative orders are open for comment. Proposed Administrative Order OTC000038 If finalized, this proposed order will specify...
Jun 17, 2025 | Drugs, FDA and USDA Regulatory Update
For Immediate Release: June 17, 2025 The U.S. Food and Drug Administration today announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans. The new voucher may be redeemed by drug developers to participate in a...
May 21, 2025 | Drug and Device Corner, Drugs, Medical Devices
Reminder that OMUFA FY2025 facility user fees are due Monday 2 June 2025. MDF fee is $37,556; CMO fee is $25,037. Please see the FDA website for full details. Do note below the agency will be providing an OMUFA user fee and registration webinar Tuesday 20 May 2025....
