10-12 - APPLICATION INTEGRITY POLICY

The Application Integrity Policy (AIP) describes the Agency's approach regarding the review of applications that may be affected by wrongful acts that raise significant questions regarding data reliability. FDA published this policy, formally entitled, "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities; Final Policy" in the Federal Register on September 10, 1991 (56 FR 46191), and in Compliance Policy Guide (CPG) 7150.09 (see Sec. 120.100 of the Compliance Policy Guides publication). These documents, procedures to implement the AIP, and AIP information are available on the Internet at: http://www.fda.gov/ora/compliance_ref/aip_page.html.