On This Page Visit CDER Small Business and Industry Assistance (SBIA) HomepageAbout this Event (Hosted by CDER SBIA)The Food and Drug Administration issued the final guidance for industry entitled “Standardized Format for Electronic Submission of NDA and BLA Content...

On This Page Date: May 22, 2025 Time: 10:00 a.m. - 4:00 p.m. ET On May 22, the Reagan-Udall Foundation for the FDA, in collaboration with the Food and Drug Administration, will host a virtual public workshop on "Primary Mitochondrial Diseases."This workshop will...

Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Steven Van Borm , Ann Kathrin Ahrens, Claudia Bachofen, Ashley C. Banyard, Cathrine Arnason...

Notice to Industry: Bioresearch Monitoring Information System (BMIS) DataIn order to foster transparency and encourage information sharing within the clinical research community, FDA’s Center for Drug Evaluation and Research (CDER) maintains a bioresearch monitoring...

Summary Company Announcement Date: May 02, 2025 FDA Publish Date: May 03, 2025 Product Type: Food & Beverages Produce Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness - Salmonella Company Name: Ray & Mascari Inc Brand...