Apr 28, 2025 | Drug and Device Corner, Drugs, Medical Devices
Under GDUFA, human generic drug facilities, sites, and organizations are required to submit identification information electronically to FDA annually. These submissions are made during the month of May The following types of generic industry facilities, sites, and...
Apr 28, 2025 | FDA and USDA Regulatory Update
Special Alert: Constituent Update April 24, 2025 FSIS is withdrawing its proposed rule and determination titled “Salmonella Framework for Raw Poultry Products”, published on August 7, 2024, to further assess its approach for addressing Salmonella illnesses associated...
Apr 23, 2025 | FDA and USDA Regulatory Update, Foods
For Immediate ReleaseApril 22, 2025 The U.S. Department of Health and Human Services and U.S. Food and Drug Administration (FDA) today announced a series of new measures to phase out all petroleum-based synthetic dyes from the nation’s food supply—a significant...
Apr 21, 2025 | Extra Article
In Memoriam: Bruce Elsner We have sad news to share on the passing of Bruce Elsner who was a long-time member of the EAS family and consulting team. Bruce had over 28 years of experience working in FDA regulated Fortune 500 companies, who manufactured and packaged...
Apr 21, 2025 | FDA and USDA Regulatory Update, Foods
The FDA is planing to hire contractors to replace fired staff who supported safety inspections, including those who arranged foreign travel and tested food samples. The cuts, which include positions in communications and policy, are expected to strain the...
Apr 8, 2025 | Cosmetics, Drug and Device Corner, Drugs, Medical Devices
We want to keep our clients up to date as we learn of any changes at the FDA that will affect normal business processes. The following 3 points have come to our attention in the last few days. For any questions regarding the status of a product in the NDC Directory,...
