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FDA posts a new draft guidance entitled New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers.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