Mar 25, 2026 | Drug and Device Corner, Drugs, Medical Devices
2025 CARES reporting deadline is next Tuesday 31 March 2026! The 2026 OMUFA facility registration user fees were published in the 18 March 2026 Federal Register Vol 91, No. 51. There is a lengthy explanation describing how the agency arrived at the user fee amounts....
Mar 20, 2026 | Foods, Webinar
Responding to Food and Seafood FDA 483s Presented by Mark Moen and Jeb Hunter May 19, 2026 | 2:00 PM ET When the FDA issues a Form 483 or Warning Letter, your response is critical—and time-sensitive. How you respond can directly impact regulatory outcomes, enforcement...
Mar 19, 2026 | Dietary Supplements, FDA and USDA Regulatory Update
FDA to Host Public Meeting on the Scope of Dietary Supplement Ingredients FDA Announces Public Meeting on Dietary Supplement Ingredient Scope The U.S. Food and Drug Administration will host a public meeting on March 27, 2026, focused on exploring the scope of dietary...
Mar 18, 2026 | FDA and USDA Regulatory Update, Foods
FDA Withdraws Temporary COVID FSMA Guidances Related to Onsite Audits FDA Ends COVID-Era Flexibility for FSMA Onsite Audit Requirements The U.S. Food and Drug Administration has announced it is withdrawing two temporary guidances issued during the COVID-19 public...
Mar 9, 2026 | Biologics, FDA and USDA Regulatory Update
FDA Announces New Steps to Streamline Biosimilar Development FDA Takes Additional Steps to Support Biosimilar Development The U.S. Food and Drug Administration has announced new actions aimed at streamlining the development of biosimilar medicines and improving access...
Mar 9, 2026 | Drugs, FDA and USDA Regulatory Update
FDA Finalizes Rule Standardizing National Drug Code Format FDA Final Rule Revises National Drug Code Format and Barcode Requirements FDA has issued a final rule revising the format of the National Drug Code (NDC) and updating certain drug label barcode requirements....
