An FDA advisory committee votes 7 to 3 that a BrainsGate PMA for its Ischemic Stroke System did not demonstrate that the devices benefits outweigh its...
Federal Register notice: FDA makes available a draft guidance entitled Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment.
FDA places clinical holds on Merck INDs for islatravir for HIV-1 pre-exposure prophylaxis due to decreases in total lymphocyte and CD4+ T-cell counts ...
FDA Review posts the Federal register notices for the week ending 12/10/2021.
FDA Review posts product approval summaries for the week ending 12/10/2021.
Federal Register notice: FDA reopens the comment period on a draft guidance entitled Real-World Data: Assessing Electronic Health Records and Medical ...
Federal Register notice: FDA sends to OMB an information collection revision entitled Labeling Requirements for Prescription Drugs.