Delegations of authority and organization; Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and Center for Drug Evaluation and Research--FDA. Final rule.
The Food and Drug Administration (FDA) is amending the regulations for delegations of authority relating to premarket approval of products that are or contain a biologic, a device, or a drug. The amendment grants directors, deputy directors, and certain other supervisory personnel in the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Drug Evaluation and Research (CDER) reciprocal premarket approval authority to approve such products.
D001688:Biological Products / Q000592:standards; D003659:Decision Making, Organizational; D004341:Drug Evaluation / Q000379:methods; D004864:Equipment and Supplies / Q000592:standards; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*
D001688:Biological Products