Investigational new animal drug

Figure 7.1 Information supplied to the CVM in support of a Notice of Claimed Investigational Exemption (NCIE) for an Investigational New Animal Drug (INAD).

Caution. Contains a new animal drug for use only in investigational animals in clinical trials. Not for use in humans. Edible products of investigational animals are not to be used for food unless authorization has been granted by the U.S. Pood and Drug Administration or by the U.S. Department of Agriculture. 

The FDA regulations or guidelines prescribe the types of safety tests for a particular product. Sponsors may conduct the studies in their own laboratories or have them performed by a contract laboratory, a university, or some other type of laboratory. The sponsor submits the study reports to the FDA in food and color additive petitions, investigational new drug applications, new drug applications, new animal drug applications, biological product license applications, and other requests for permission to market a product. 

Pharmaceutical firms have to reexamine their strategies to devise means to increase their drug pipelines for continuous streams of products. The high failure rates of Investigational New Drugs during clinical trials (see Exhibit 5.8) necessitate the development of better assay systems and animal models that correlate closely with human pharmacodynamics and pharmacokinetics. The study of pharmacogenomics will be crucial to address this issue. 

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