Application Integrity Policy Information
- 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.
- 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.
- Points to Consider for Internal Reviews and Corrective Action
Plans.
- Regulatory Procedures Manual, Subchapter 10, "Application
Integrity Policy".
- RPM Subchapter 10, FDA AIP Contact List
- Compliance Policy Guide 7150.09, Sec. 120.100, "Fraud, Untrue Statements of Material Facts, Bribery,
and Illegal Gratuities".
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