21 C.F.R. § 312.86 Focused FDA regulatory research.
Title 21 - Food and Drugs
At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical, chemical/manufacturing, and clinical phases of drug development and evaluation. When initiated, FDA will undertake such research efforts as a means for meeting a public health need in facilitating the development of therapies to treat life-threatening or severely debilitating illnesses.
Title 21: Food and Drugs
PART 312—INVESTIGATIONAL NEW DRUG APPLICATION
Subpart E—Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses
§ 312.86 Focused FDA regulatory research.
