21 CFR 312.38

§ 312.38 Withdrawal of an IND.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 312.38, § 312.38 Withdrawal of an IND, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86274
Permanent ID: ys:prov:86274@1
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Full text

(a) At any time a sponsor may withdraw an effective IND without prejudice. (b) If an IND is withdrawn, FDA shall be so notified, all clinical investigations conducted under the IND shall be ended, all current investigators notified, and all stocks of the drug returned to the sponsor or otherwise disposed of at the request of the sponsor in accordance with § 312.59. (c) If an IND is withdrawn because of a safety reason, the sponsor shall promptly so inform FDA, all participating investigators, and all reviewing Institutional Review Boards, together with the reasons for such withdrawal.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.