Federal Register notice: FDA reopens the comment period on a draft guidance entitled Elemental Impurities in Animal Drug Products Questions and Answe...
FDA announces a 9/20 advisory committee meeting to discuss modernizing its NDA assessments through a Knowledge-Aided Assessment and Structured Applica...
FDA warns Apotex Research Private about recurring CGMP violations at its drug manufacturing facility in Bangalore, India, as well as other company sit...
FDA clears a BioSig Technologies 510(k) for the Pure EP System, a computerized system intended for acquiring, digitizing, amplifying, filtering, measu...
FDA grants MolecuLight de novo classification allowing marketing of its wound fluorescence imaging device, the MolecuLight i:X.
Researchers say more recalls occur with foot and ankle medical devices cleared through 510(k)s than approved through PMAs.
Federal Register notice: FDA withdraws the approval of 20 ANDAs from multiple applicants.
Federal Register notice: FDA submits to OMB a new information collection request entitled Experimental Study of Risk Information Amount and Location i...