FDA publishes a final guidance to assist sponsors in submitting human factors information with medical device marketing applications to fit the FDA ri...
FDA warns Springfield, MA-based physician Adnan Dahdul about Bioresearch Monitoring violations in his conduct of a clinical investigation.
FDA extends by 30 days the comment period on a request for information entitled AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program."...
Eli Lilly says it is acquiring three vaccine developers in deals worth up to $3.8 billion combined, expanding its push into infectious disease prevent...
FDA cites Dabur India Limited for significant manufacturing and data integrity violations at an over-the-counter drug manufacturing facility in India.
Researchers say manufacturers could make better use of predetermined change control plans for AI-enabled medical devices.
A Cooley legal analysis notes that FDA and federal prosecutors are signaling a tougher stance on failures to report patient safety issues to regulator...
FDA warns Alsip, IL-based GC America about CGMP violations in its production of finished drugs.
