In the August 24, 2016, Federal Register, FDA proposed expanding the scope of clinical investigator disqualification in its regulations for new animal drugs for investigational use to include ineligibility to conduct nonclinical laboratory studies. Currently, when the Commissioner of Food and Drugs ("Commissioner") determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also is ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. Under FDA's proposal, when the Commissioner determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also will be ineligible to conduct any nonclinical study intended to support an application for a research or marketing permit for a new animal drug. With this proposal, FDA intends to help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA. Comments are due November 22, 2016.
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