FDA posts a draft guidance entitled Failure to Respond to an ANDA Complete Response Letter Within 1 the Regulatory Timeframe.
Federal Register notice: FDA corrects a notice that appeared in the 7/21 Federal Register announcing the withdrawal of approval for two ANDAs from Kad...
Federal Register notice: FDA issues a final rule to allow importation of certain prescription drugs from Canada.
FDA approves a Shionogi & Co. supplemental NDA for Fetroja (cefiderocol) for treating patients 18 years of age or older with hospital-acquired bacteri...
FDA posts an International Council for Harmonization draft guidance entitled M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharm...
FDA vaccines advisory committee chair Hana El Sahly recuses herself from reviewing any upcoming pandemic vaccines because of her role overseeing a Mod...
FDA issues Assure Tech an emergency use authorization for the first serology (antibody) point-of-care test for Covid-19.