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In this section: Compliance Actions and Activities

Application Integrity Policy

Application Integrity Policy List - Names of firms that 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.
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".

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