[ Price : $8.95]
Federal Register notice: FDA amends its standing advisory committee regulations to add the new Digital Health Advisory Committee.[ Price : $8.95]
FDA cautions device manufacturers to evaluate the performance data provided by third-party labs for use in agency submissions.[ Price : $8.95]
CBER publishes a SOPP for the administrative handling, review, and reporting of postmarketing requirements and commitment submissi...[ Price : $8.95]
Two Coalition for a Prosperous America policy experts outline steps they say the federal government, including FDA and Congress, c...[ Price : $8.95]
An FDA-funded survey of doctors who prescribe REMS-covered drugs finds that many doctors appreciate and use the REMS information a...[ Price : $8.95]
FDA clears an X-trodes 510(k) for its X-trodes Smart Skin device, a wireless wearable technology for advanced electrophysiological...[ Price : $8.95]
FDA grants Harmony Biosciences Holdings an orphan drug designation for pitolisant and its use in treating Prader-Willi syndrome.[ Price : $8.95]
FDA accepte for priority review a Merck supplemental BLA for Keytruda in combination with standard-of-care chemotherapy for treati...