FDA announced on Tuesday, June 24, 2025, that it has updated Compliance Program 7321.005, now titled General Food Labeling ...

The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...

The new educational videos titled, “Important Aspects of the NDIN Process” and “Correspondence Between FDA and the Notifier,” work together to provide an overview of the entire NDIN process.

The inspection took place from February 10 to 20, and the FDA’s final response was dated June 11. The company’s facilities at Biocon Park are core to its operations.

Syngene International said that the United States Food and Drug Administration (US FDA) conducted a good clinical practices (GCP) compliance inspection of the company's facility located at Semicon ...

According to a regulatory filing by the company, the US FDA conducted a Good Manufacturing Practices (GMP) inspection at the Halol site from June 2 to June 13, 2025.

NATCO Pharma announced conclusion of US FDA Inspection at its Mekaguda, Hyderabad Active Pharmaceutical Ingredients (API) Unit The U.S. Food and Drug Administration (FDA) had conducted an inspection ...

Capricor Therapeutics announced that it has successfully completed the U.S. FDA's Pre-License Inspection of its San Diego manufacturing facility for its lead therapy candidate, Deramiocel, aimed ...

FDA is announcing a hybrid public meeting to begin the reauthorization process for MDUFA, the legislation that authorizes FDA to collect user fees to support the process for the review of medical ...

FDA Commissioner Marty Makary aims to form a proactive agency to spur an agenda to examine ultraprocessed foods, food additives, and environmental toxins. ... FDA Chief Prioritizes Fast Approval ...

Dr. Marty Makary, the Food and Drug Administration commissioner, wrote an article in the journal JAMA arguing that A.I. would “radically increase efficiency” in the process of deciding whether ...