FDA Aligns New Pharmaceutical Inspectorate Into Six Divisions
US FDA’s structure for its new pharmaceutical inspectorate, part of the massive reorganization of the Office of Regulatory Affairs, includes four domestic divisions, a fifth handling foreign inspections and the sixth handling program functions. New staff directory could prove valuable to pharmaceutical companies learning to interact with a very different field organization.
You may also be interested in...
Poor inspection history was dropped as a criteria for unannounced inspections, OIG says in an audit report, even as support grows for surprise inspections of poor quality sites. An exhaustive review of foreign for-cause inspections shows the FDA reorganization has sped up a process that must go faster still. Meanwhile, whatever happened to experienced investigators’ training records?
Commissioner Robert Califf wants Janet Woodcock to improve food operations and processes, but lawmakers question whether she is the best overseer for the area.
Commissioner Robert Califf wants Woodcock to improve food operations and processes, but lawmakers question whether she is the best overseer for the area.