title: Administrative practices and procedures; internal agency review of decisions--FDA. Direct final rule; withdrawal.
abstract: The Food and Drug Administration (FDA) published in the Federal Register of June 16, 1998 (63 FR 32733), a direct final rule to implement the new Dispute Resolution provision of the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The comment period closed on August 31, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.
mesh_terms: D003659:Decision Making, Organizational; D018795:Device Approval / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D010380:Peer Review / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration