Application Integrity Policy

• Application Integrity Policy List - Names of firms that were notified that FDA is deferring substantive scientific review of one or more of the firm's applications and/or is proceeding to withdraw approved applications.
• Application Integrity Policy Procedures (PDF 153 kb)
• FDA Application Integrity Policy (AIP) Contact List
• Federal Register Notice - Fraud, untrue statements of material facts, bribery and illegal gratuities; Final Policy September 11, 1991.
• Points to Consider for Internal Reviews and Corrective Action Plans.
• Regulatory Procedures Manual, Subchapter 10, has a brief statement about "Application Integrity Policy" (PDF 137 kb)
• Compliance Policy Guide 7150.09, Sec. 120.100, "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities".