21 C.F.R. § 312.87 Active monitoring of conduct and evaluation of clinical trials.
Title 21 - Food and Drugs
For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and be involved in facilitating their appropriate progress.
Title 21: Food and Drugs
PART 312—INVESTIGATIONAL NEW DRUG APPLICATION
Subpart E—Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses
§ 312.87 Active monitoring of conduct and evaluation of clinical trials.