Regulatory guidance and governance

Manufacturing information These data address the composition, manufacture, stability, and controls used for manufacturing the drug. 

Investigator information Information on the qualifications of clinical investigators is provided to allow assessment of whether they are qualified to fulfill their duties at the investigational sites used during the clinical trials. 

As the IND progresses further clinical study protocols and the results of completed studies (manufacturing, nonclinical, and clinical) are submitted, and the IND grows accordingly. 

When the clinical development program is complete and all nonclinical studies being conducted contemporaneously are complete, the sponsor submits a new drug application (NDA) (in the case of a biologic product, a biologies license application [BLA] is submitted). Typically, 

While the ICH publishes an extensive list of guidances, the FDA also publishes guidances for industry that can be very helpful and can be located via the FDA s website (www.fda.gov). 

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