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Federal Register notice: FDA makes available a final guidance entitled Submitting Documents Using Real-World Data and Real-World E...[ Price : $8.95]
FDA publishes a final guidance on identifying real-world data and real-world evidence submitted in INDs, NDAs, and BLAs.[ Price : $8.95]
FDA denies a petition seeking a Boxed Warning for excimer lasers used in LASIK procedures.[ Price : $8.95]
Sklip Inc. receives IRB approval to clinically test its Sklip artificial intelligence skin cancer triage system with patients in h...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Neurocrine Biosciences Oril...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection revision entitled General Drug Labeling Provisions and OT...[ Price : $8.95]
The Union of Concerned Scientists says it will be asking scientists in seven federal agencies to describe the state of science in ...[ Price : $8.95]
FDA says its monitoring of breast implants has detected some cases of squamous cell carcinoma and various lymphomas in the scar ti...