Sep 16, 2025 | Drugs, FDA and USDA Regulatory Update
FDA has issued a final guidance on how the agency intends to use alternative tools in advance, in lieu of, or in support of preapproval and prelicense inspections to remotely evaluate drug manufacturing facilities named in pending applications as part of FDA’s drug...
Sep 8, 2025 | Dietary Supplements, FDA and USDA Regulatory Update, Foods
Heads-up: Front-of-Pack labels, GRAS changes, and supplement definition update FDA has signaled three significant rulemakings in the Unified Agenda that could affect food and dietary supplement companies. These are not official final rules—but they’re far enough along...
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...
Sep 3, 2025 | FDA and USDA Regulatory Update, Foods
September 02, 2025 Constituent Update Read on FDA Website The U.S. Food and Drug Administration (FDA) is releasing the results from a sampling assignment conducted during 2022 to 2024 on testing of frozen seafood products for short weighting. Short weighting can occur...
Sep 2, 2025 | FDA and USDA Regulatory Update, Tobacco
September 02, 2025 FDA News Release Read on FDA Website The U.S. Food and Drug Administration calls on nicotine pouch manufacturers to use child-resistant packaging to protect American children from accidental, harmful exposure. From April 1, 2022, to March 31, 2025,...
Aug 19, 2025 | FDA and USDA Regulatory Update, Foods
FDA to Hold Virtual Public Meeting and Listening Sessions on Food Allergen Thresholds and Their Potential Applications August 18, 2025 Constituent Update Read on FDA Website Save the Date Dates Virtual Presentations and Panel Discussions – November 18, 2025 Virtual...
