Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities. FDA Compliance Policy Guides 7150.09. Chapter 50. General Policy

摘要

The policy sets forth FDA's regulatory approach regarding applicants that seek to subvert the agency's review and approval processes for premarket applications. The policy also outlines recommended corrective actions by which applicants may seek to restore FDA's confidence in their integrity and permit the agency to proceed with substantive scientific review of their premarket applications.