FDA civil money penalties final rule outlines plan for consistent application.
Executive Summary
FDA CIVIL MONEY PENALTIES CONSISTENT APPLICATION BY AGENCY will be assured by "coordinating procedures" to be established by the Office of Enforcement in FDA's Office of Regulatory Affairs, the agency states in a final rule published in the July 27 Federal Register. The procedures are intended to ensure that "enforcement discretion" is exercised "in a fair and reasonable manner," the notice states.