21 CFR 312.86
§ 312.86 Focused FDA regulatory research.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 312.86, § 312.86 Focused FDA regulatory research, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86308
- Permanent ID
ys:prov:86308@1- SHA-256
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.