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....
May 13, 2025 | Cannabis, Cosmetics, Dietary Supplements, Drugs, FDA and USDA Regulatory Update, Foods, Medical Devices, Tobacco, Veterinary
HHS, FDA Issue RFI on Deregulatory Plan to Lower Costs and Empower Providers May 13, 2025 View on the FDA Website The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced the launch of a public Request for...
May 7, 2025 | Cosmetics, Dietary Supplements, Drugs, FDA and USDA Regulatory Update, Foods, Medical Devices, Tobacco, Veterinary
May 06, 2025 Today, the U.S. Food and Drug Administration announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and...
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...
