Rep. Jake Auchincloss (D-MA) criticizes FDAs new voucher program that offers select drugmakers sharply shortened review timelines, arguing the program...
Acting CDER director Tracy Beth Hoeg looks to hire the petitioner behind a request the Center is considering to add new Warnings to commonly prescribe...
FDA posts the form FDA-483 with six observations from a 2023 inspection at the Fujian Genohope Biotech sterile drug manufacturing facility in Fujian, ...
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 ...
