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$...
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 The agency has rescinded the FDA review exemption that had previously been applicable to importation of certain low-value FDA regulated products.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...
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...
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....
Apr 28, 2025 | Drug and Device Corner, Drugs, Medical Devices
Under GDUFA, human generic drug facilities, sites, and organizations are required to submit identification information electronically to FDA annually. These submissions are made during the month of May The following types of generic industry facilities, sites, and...
Apr 8, 2025 | Cosmetics, Drug and Device Corner, Drugs, Medical Devices
We want to keep our clients up to date as we learn of any changes at the FDA that will affect normal business processes. The following 3 points have come to our attention in the last few days. For any questions regarding the status of a product in the NDC Directory,...
