Application Integrity Policy

Quality checks of submissions are critical to ensure that methods, processes, equipment, and facilities have been accurately reported and that the documents included in the submission represent the appropriate scope of information. In addition, the actual data presented in the submission must be checked for integrity and accuracy to the extent possible. The submission of inaccurate or fraudulent documents could result in the invocation of the fraud policy or the application integrity policy (AIP) that covers the failure to have and implement systems or procedures to ensure the quality and accuracy of submissions. It is therefore clear that ensuring the quality of submissions and authenticating all data is critical to maintaining the good compliance standing of the applicant. 

Center for Biologies Evaluation and Research (CBER). Manual of Standard Operating Procedures and Policies, SOPP 8001.2. Accessing the FDA Lists of Disqualified and Restricted Clinical Investigators, Debarred Individuals, and Firms Under the FDA Application Integrity Policy, April 1, 1998. 

U.S. regulatory ramifications for non-compliance include invoking the application integrity policy (for fraud), serious inspection observations, a warning letter, import alerts, withheld research and/or product approvals, cancellation of government contracts, product recalls, seizure, consent decree of permanent injunction, civil money penalties, suspension or revocation of licenses, and prosecution (including indictments and temporary or permanent debarment, if found guilty). ... 

As a consequent further development of LCA and LCE, LCS is expected to become the basis for future integrated sustainability decision support on the level of products / services and processes. It is a tool, developed for use in industry, but is expected to find application in policy making, too. 

The grant application was written and submitted while I was at the Health Law and Policy Institute of the University of Houston. My former colleague, Elaine Lisko, who left Houston in 1999, played an integral part in... 

Constructive prospects to solution of this problem are connected with the development and application of complex models to evaluate possible changes in climate and socio-economic development. Parson and Fisher-Vanden (1997,1999) and Dess-ler and Parson (2005) prepared a detailed overview of the methods and results of numerical modeling of global climate changes with the dynamics of socio-economic processes taken into account, in which basic aspects of so-called integrated assessments (IAs) were discussed. The main goal of such developments is substantiation of recommendations for decision-makers in the sphere of ecological policy. 

Added Substances (Policy) FCC specifications are intended for application to individual substances (single entities) and not to proprietary blends or other mixtures. Some specifications, however, allow added substances (i.e., functional secondary ingredients such as anticaking agents, antioxidants, diluents, emulsifiers, and preservatives) intentionally added when necessary to ensure the integrity, stability, utility, or functionality of the primary substance in commercial use. 

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