FDA publishes a final guidance on identifying real-world data and real-world evidence submitted in INDs, NDAs, and BLAs.
FDA denies a petition seeking a Boxed Warning for excimer lasers used in LASIK procedures.
Sklip Inc. receives IRB approval to clinically test its Sklip artificial intelligence skin cancer triage system with patients in home settings.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Neurocrine Biosciences Orilissa (elagolix sodiu...
Federal Register notice: FDA seeks comments on an information collection revision entitled General Drug Labeling Provisions and OTC Monograph Drug Use...
The Union of Concerned Scientists says it will be asking scientists in seven federal agencies to describe the state of science in their agencies under...
FDA says its monitoring of breast implants has detected some cases of squamous cell carcinoma and various lymphomas in the scar tissue around the impl...
FDA publishes an immediately effective guidance on emergency use authorizations for monkeypox diagnostic tests.
