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The Washington DC District Court rules against FDA in granting a Ferring motion for reconsideration over how FDA decided not to re...[ Price : $8.95]
Federal Register notice: FDA posts a list of information collections that have been approved by the Office of Management and Budge...[ Price : $8.95]
Federal Register notice: FDA releases a draft guidance on 510(k) Third Party Review Program.[ Price : $8.95]
Federal Register notice: FDA seeks nominations for voting members to serve on the Tobacco Products Scientific Advisory Committee.[ Price : $8.95]
FDA reviewers see concerns with the ascertainment of the primary neuropsychiatric adverse event outcome that impacts interpretatio...[ Price : $8.95]
FDA approves an Obalon Therapeutics PMA for the Obalon Balloon System, a nonsurgical, reversible device for weight loss.[ Price : $8.95]
FDA grants BioVie an orphan drug designation for BIV201 for treating ascites due to all causes except cancer.[ Price : $8.95]
GE Healthcare gains 510(k) clearance for MAGiC (Magnetic Resonance Image Compilation), which is a customized version of SyntheticM...