Jul 10, 2025 | Drugs, FDA and USDA Regulatory Update
FDA News Release July 10, 2025 View on FDA Website The U.S. Food and Drug Administration (FDA) today published more than 200 decision letters, known as complete response letters (CRLs). The CRLs were issued in response to applications submitted to the FDA for approval...
Jul 7, 2025 | Foods, Issue of the Month
Comparative Perspective on Thermal Processing: Regulations and Practices in Mexico and the U.S. By Fernanda Estefanía Jiménez Garzón, EAS Consulting Group Independent Consultant What if the foodborne illness you experienced… could have been prevented? According to the...
Jul 1, 2025 | FDA and USDA Regulatory Update, Foods
The following list of guidance topics includes possible new topics for guidance documents or revisions to existing guidance documents that the FDA is considering for Human and Animal Foods. The lists below include some of the guidance documents under consideration to...
Jun 24, 2025 | FDA and USDA Regulatory Update, Foods
Constituent Updates June 24, 2025 Read on FDA Website The U.S. Food and Drug Administration has updated Compliance Program 7321.005, now titled General Food Labeling Requirements and Labeling-Related Sample Analysis – Domestic and Import. This update replaces the...
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 18, 2025 | FDA and USDA Regulatory Update, Foods
Constituent Update June 18, 2025 Today, the U.S. Food and Drug Administration (FDA) released for public comment its proposed method for ranking chemicals in the food supply. This method provides a transparent, systematic, and science-based approach to determine which...