Jan 29, 2024 | Drug and Device Corner, Drugs, Medical Devices
Reminder that per the CARES Act of 2020, drug establishments are required to report NDC volumes annually. This applies to all facilities that manufacture, prepare, propagate, compound, or process drugs for commercial distribution in the United States. Although the FDA...
Jan 29, 2024 | FDA and USDA Regulatory Update, Foods
On January 25, 2024, the U.S. Food and Drug Administration’s Foods Program posted a list of new / updated food regulations it plans to publish in 2024 and beyond. These include: Amendments to Registration of Food Facilities February 2024. The proposed rule would make...
Jan 24, 2024 | Drugs, FDA and USDA Regulatory Update, Veterinary
The FDA has announced the availability of a draft guidance for industry #286 (VICH GL60): “Good Manufacturing Practice for Active Pharmaceutical Ingredients used in Veterinary Medicinal Products.” This draft guidance has been developed by the International Cooperation...
Jan 5, 2024 | Foods, Issue of the Month
Shaping the Future: Revolutionizing Food Safety and Quality By Vera K. Petrova Dickinson, EAS Independent Consultant In the ever-evolving landscape of the food industry, the quest for ensuring Food Safety and Quality (FSQ) faces both new challenges and age-old...
Dec 29, 2023 | Drug and Device Corner
With the requirement for Cosmetic Responsible Persons to report Serious Adverse Events to FDA beginning 29 December 2023, the agency has recommended using the current Form 3500A that is downloadable and fillable at MedWatch: The FDA Safety Information and Adverse...
Dec 14, 2023 | Cosmetics, FDA and USDA Regulatory Update
Today, the U.S. FDA has provided an update on its ongoing activities related to serious adverse event reporting mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which are enforceable starting December 29, 2023. A responsible person is...
