Mar 28, 2023 | Drug and Device Corner, Drugs, Medical Devices
The FDA has announced the 2023 OMUFA user fee rates, please see the Over-The-Counter Monograph Drug User Fee Program (OMUFA) website for full details. Monograph Drug Facility (MDF) Facility fee: $26,153; Contract manufacturing Organization (CMO) Facility Fee: $17,435....
Mar 9, 2023 | FDA and USDA Regulatory Update, Foods
On March 8, 2023, US FDA issued a “Call to Action” letter to all powdered infant formula manufacturers, packers, distributors, exporters, importers, and retailers in order to help protect our most vulnerable population. The FDA has reviewed conditions during recent...
Mar 9, 2023 | FDA and USDA Regulatory Update, Foods
The US Department of Agriculture Food Safety Inspection Service (USDA FSIS) announced draft of a proposed change to voluntary labeling requirements for meat, poultry and eggs that use the claim ‘Made in the USA’ or ‘Product of the USA.’ Under the proposed change, use...
Mar 8, 2023 | Foods, Issue of the Month
Developing a Food Safety Culture: Challenges and Best Practices By Angie Surtani, EAS Consulting Group Independent Consultant Food safety culture is a journey that requires significant hard work, time, effort, persistence, and commitment for fruition. I consider food...
Mar 6, 2023 | Dietary Supplements, FDA and USDA Regulatory Update
FDA has launched an on-line directory that lists 27 articles used in dietary supplements enabling quick references to any information FDA currently has pertaining to these articles and any actions taken such as constituent updates and warning letters. Additionally,...
Feb 27, 2023 | Drug and Device Corner, Drugs, Medical Devices
The FDA sent email reminders in February re mandatory CARES annual reporting for drug establishments, which are due now. CARES volume reporting has been an annual requirement since passing of the CARES Act in 2020. If you have not already submitted your 2020 and 2021...
