Administrative practices and procedures; internal review of decisions--FDA. Final rule.
The Food and Drug Administration (FDA) is amending the regulations governing the internal review of agency decisions by inserting a statement that sponsors, applicants, or manufacturers of drugs (including human drugs, animal drugs, and human biologics) or devices may request review of a scientific controversy by an appropriate scientific advisory panel, or advisory committee. This amendment implements the "Dispute Resolution" provision of the Food and Drug Administration Modernization Act (FDAMA). This document is intended to clarify that sponsors, applicants, or manufacturers of drugs, or devices may request review of scientific controversies by an appropriate scientific advisory panel or advisory committee.
D003659:Decision Making, Organizational; D018795:Device Approval; D017277:Drug Approval / Q000458:organization & administration*; D014481:United States; D014486:United States Food and Drug Administration