Delegations of authority and organization; 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 the approval of new drug applications (NDA's), abbreviated new drug applications (ANDA's), and their supplements to add the Deputy Director (Medical and Scientific Affairs), Center for Drug Evaluation and Research (CDER), to the list of officials authorized to approve certain NDA's, ANDA's, and their supplements for drugs for human use. In addition, FDA is adding authority to approve applications submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (505(b)(2) applications) to these officials. These authorities were given to FDA under section 505 of the act.
D003659:Decision Making, Organizational; D017277:Drug Approval / Q000458:organization & administration*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*