FDA watchers need patience as they wait to see who president-elect Donald Trump chooses to nominate as the next FDA commissioner.
FDA identifies four trends in IRB violations from FDA-483s issued in FY 2023.
Public Citizen preemptively criticizes expected 2025 legislation to authorize FDA to approve drugs for rare diseases based on substantial evidence rat...
Federal Register notice: FDA issues a proposed administrative order to remove orally administered phenylephrine in OTC nasal decongestants.
FDA cites a lack of adequate training in FY 2023 Good Laboratory Practice inspection form FDA-483s.
FDA approves the J&J Varipulse pulsed field ablation platform to treat atrial fibrillation.
Based on safety concerns, Sarepta says it is discontinuing the development of SRP-5051 (vesleteplirsen) for treating patients with Duchenne muscular d...
FDA grants de novo authorization to LumiTheras Valeda light delivery treatment for dry age-related macular degeneration.
