Delegations of authority and organization; new drug applications--Food and Drug Administration. Final rule.
The Food and Drug Administration (FDA) is amending the regulations for delegations of authority regarding approval of new drug applications (NDA's) by redelegating to the Directors of Divisions conducting new drug evaluations authority to approve an additional class of NDA's to expedite the approval process. Published elsewhere in this issue of the Federal Register is a notice reorganizing the Bureau of Drugs and Bureau of Biologics into the National Center for Drugs and Biologics. This document also updates organizational references in accordance with the reorganization.
D004341:Drug Evaluation / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration