FDA issues a guidance entitled ANDA Submissions Amendments and Requests for Final Approval to Tentatively Approved ANDAs.
Federal Register notice: FDA announces an 11/6 Advisory Committee meeting to review a Biogen BLA for aducanumab solution for treating Alzheimers disea...
FDA posts a draft guidance entitled Failure to Respond to an ANDA Complete Response Letter Within 1 the Regulatory Timeframe.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FDA posts an International Council for Harmonization draft guidance entitled M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharm...