Federal Register notice: FDA makes available a final guidance for industry entitled Q3C (R8) Impurities: Guidance for Residual Solvents.
A U.S. House Oversight and Reform Committee staff report alleges troubling issues with drug companies rising prices and actions to manipulate the pate...
FDA approves an Urotronic PMA for Optilume Urethral Drug Coated Balloon for use in male urethral strictures.
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Federal Register notice: FDA makes available a draft guidance entitled Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment.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.