FDA cautions device manufacturers to evaluate the performance data provided by third-party labs for use in agency submissions.
CBER publishes a SOPP for the administrative handling, review, and reporting of postmarketing requirements and commitment submissions.
Two Coalition for a Prosperous America policy experts outline steps they say the federal government, including FDA and Congress, can take to address c...
An FDA-funded survey of doctors who prescribe REMS-covered drugs finds that many doctors appreciate and use the REMS information and want more informa...
FDA clears an X-trodes 510(k) for its X-trodes Smart Skin device, a wireless wearable technology for advanced electrophysiological monitoring.
FDA grants Harmony Biosciences Holdings an orphan drug designation for pitolisant and its use in treating Prader-Willi syndrome.
FDA accepte for priority review a Merck supplemental BLA for Keytruda in combination with standard-of-care chemotherapy for treating patients with end...
ARS Pharmaceuticals says new study data will be submitted in the second quarter as part of a response to a 9/2023 FDA complete response letter on an N...
