Aug 28, 2024 | Drug and Device Corner, Drugs, Extra Article, Medical Devices
FDA issued a proposed administrative order to amend the requirements for internal analgesic, antipyretic, and antirheumatic drug products for OTC human use, as currently described in OTC Monograph M013. The proposed change will require the addition of a warning to the...
Aug 19, 2024 | FDA and USDA Regulatory Update, Tobacco
Recently, FDA and the Department of the Treasury are announcing a proposed rule that would require an importer to submit the FDA-issued Submission Tracking Number (STN) of Electronic Nicotine Delivery System (ENDS) products into the electronic imports system operated...
Aug 1, 2024 | Cannabis, Cosmetics, Dietary Supplements, Drugs, Foods, Issue of the Month, Medical Devices, Tobacco, Veterinary
How to Build an Achieving Team By Eiman Raouf, EAS Senior Regulatory Consultant Upon entering various organizations, scenarios often unfold where operational efficiency falls short. Quality lapses in production, a surge in customer grievances, or perpetual crisis...
Jul 30, 2024 | Dietary Supplements, FDA and USDA Regulatory Update
9 Out Of 10 American Adults Support Listing Requirements For Dietary Supplements WASHINGTON – U.S. Senate Majority Whip Dick Durbin (D-IL) today introduced the Dietary Supplement Listing Act of 2024, legislation to require dietary supplement manufacturers to list...
Jul 29, 2024 | Cosmetics, FDA and USDA Regulatory Update
Cosmetics Constituent Update Today the U.S. Food and Drug Administration (FDA) announced the release of the following enhancements to help industry keep their registration and listing submissions up to date: the availability of two new features in Cosmetics Direct,...
Jul 25, 2024 | Drug and Device Corner, Drugs, Medical Devices
FDA has sent notices to drug establishment registrants reminding OTC hand sanitizer manufacturers who entered the market solely to provide hand sanitizer during the COVID-19 public health emergency, that beginning FY2025 OMUFA facility user fees will become mandatory....
