GroundRules
21 CFR 312.86: Focused FDA regulatory research.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER D—DRUGS FOR HUMAN USE
- PART 312—INVESTIGATIONAL NEW DRUG APPLICATION
- Subpart E—Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON