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FDA issues a guidance entitled ANDA Submissions Amendments and Requests for Final Approval to Tentatively Approved ANDAs.[ Price : $8.95]
Federal Register notice: FDA announces an 11/6 Advisory Committee meeting to review a Biogen BLA for aducanumab solution for treat...[ Price : $8.95]
FDA posts a draft guidance entitled Failure to Respond to an ANDA Complete Response Letter Within 1 the Regulatory Timeframe.[ Price : $8.95]
Federal Register notice: FDA corrects a notice that appeared in the 7/21 Federal Register announcing the withdrawal of approval fo...[ Price : $8.95]
Federal Register notice: FDA issues a final rule to allow importation of certain prescription drugs from Canada.[ Price : $8.95]
FDA approves a Shionogi & Co. supplemental NDA for Fetroja (cefiderocol) for treating patients 18 years of age or older with hospi...[ Price : $8.95]
FDA vaccines advisory committee chair Hana El Sahly recuses herself from reviewing any upcoming pandemic vaccines because of her r...[ Price : $8.95]
FDA issues Assure Tech an emergency use authorization for the first serology (antibody) point-of-care test for Covid-19.