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Code of Federal Regulations Title 21. Food and Drugs § 21.312.38 Withdrawal of an IND

Current as of January 02, 2025 | Updated by Findlaw Staff

(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(b) If an IND is withdrawn, FDA shall be so notified, all clinical investigations conducted under the IND shall be ended, all current investigators notified, and all stocks of the drug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(c) If an IND is withdrawn because of a safety reason, the sponsor shall promptly so inform FDA, all participating investigators, and all reviewing Institutional Review Boards, together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.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.312.38 Withdrawal of an IND - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-312-38/

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