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FDA denies an Age Reversal Unity petition asking the agency to establish a framework and issue guidance for expedited clinical tri...[ Price : $8.95]
FDA warns Phoenix, AZ-based Diasol, Inc., about multiple Quality System and Medical Device Reporting violations in its illegal man...[ Price : $8.95]
FDA denies a BioMarin petition asking it not to approve any C-type natriuretic peptides to treat achondroplasia until the expirati...[ Price : $8.95]
FDA grants Vanda Pharmaceuticals a long-sought formal evidentiary public hearing to review the agencys proposal to refuse approval...[ Price : $8.95]
FDA cites Chinese active pharmaceutical ingredient manufacturer Hubei JXBio Pharmaceutical Co for multiple deficiencies in its han...[ Price : $8.95]
FDA seeks public input on whether to revise a longstanding series of manufacturing guidance documents that govern how drugmakers m...[ Price : $8.95]
FDA posts a new draft guidance entitled New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions a...[ Price : $8.95]
FDA sends 30 Warning Letters to telehealth companies for making false or misleading claims about compounded GLP-1 medications on t...