Harmed Americans for Reform in Medical Device Safety petitions FDA to investigate the Mayo Clinics use of a robotic mastectomy device.
FDA finalizes a sweeping overhaul of the National Drug Code system, adopting a standardized 12-digit format for the identifier used to uniquely distin...
FDA places a partial clinical hold on a mid-stage U.S. trial of PepGen Inc.s experimental therapy for myotonic dystrophy Type 1.
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...
