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FDA extends its review of a Neurotech Pharmaceuticals BLA for NT-501 (revakinagene taroretcel) as a treatment for macular telangie...[ Price : $8.95]
Four stakeholders respond to an FDA request for comments on guidance development and engaging with stakeholders on model-informed ...[ Price : $8.95]
Elekta Instrument AB recalls (Class 1) its Elekta Disposable Biopsy Needle Kit for the Leksell Stereotactic System due to microsco...[ Price : $8.95]
FDA watchers need patience as they wait to see who president-elect Donald Trump chooses to nominate as the next FDA commissioner.[ Price : $8.95]
FDA identifies four trends in IRB violations from FDA-483s issued in FY 2023.[ Price : $8.95]
Public Citizen preemptively criticizes expected 2025 legislation to authorize FDA to approve drugs for rare diseases based on subs...[ Price : $8.95]
Federal Register notice: FDA issues a proposed administrative order to remove orally administered phenylephrine in OTC nasal decon...[ Price : $8.95]
FDA cites a lack of adequate training in FY 2023 Good Laboratory Practice inspection form FDA-483s.