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.
FDA extends its review of an AstraZeneca NDA for camizestrant, an experimental breast cancer therapy, after requesting additional data tied to a close...
