Application Integrity Policy Information
(NOTE: The 2004 edition of the Regulatory
Procedures Manual (RPM), Ch. 10, no longer contains the AIP procedures
and contact list. It does contain a brief
statement with a link to this page for those documents and other
related documents listed below. For example, the second bullet below
contains the procedures that were formerly contained in the RPM.)
- 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
- AIP Procedures, (HTML) ( PDF 153 kb) - Application Integrity Policy procedures March 5, 1998.
- 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
- Regulatory Procedures Manual (March 2004), Subchapter 10, (Sec. 10-9, page 28) has a brief statement about "Application Integrity Policy" (PDF 409 kb) and "FDA AIP Contact List." See the "Note" above. This line item remains on this list because the RPM contains the brief statement about AIP.
- Compliance Policy Guide 7150.09, Sec. 120.100, "Fraud, Untrue Statements of Material Facts, Bribery,
and Illegal Gratuities".