Elekta Instrument AB recalls (Class 1) its Elekta Disposable Biopsy Needle Kit for the Leksell Stereotactic System due to microscopic debris found on ...
FDA watchers need patience as they wait to see who president-elect Donald Trump chooses to nominate as the next FDA commissioner.
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 identifies four trends in IRB violations from FDA-483s issued in FY 2023.
