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 3, 2025 | FDA and USDA Regulatory Update
Download the Final Guidance Document Read the Federal Register Notice Docket Number: FDA-2022-D-0810 Issued by: Office of Inspections and Investigations Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation...
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 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...
Jun 17, 2025 | Drugs, FDA and USDA Regulatory Update
For Immediate Release: June 17, 2025 The U.S. Food and Drug Administration today announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans. The new voucher may be redeemed by drug developers to participate in a...
