§ 312.38. Withdrawal of an IND.
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/us/cfr/t21/s§ 312.38·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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(b)If an IND is withdrawn, FDA shall be so notified, all clinical investigations conducted under the IND shall be ended, all current investigators notified, and all stocks of the drug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(c)If an IND is withdrawn because of a safety reason, the sponsor shall promptly so inform FDA, all participating investigators, and all reviewing Institutional Review Boards, together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. [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 67 FR 9586, Mar. 4, 2002]
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§ 312.38
Withdrawal of an IND.
Fed. Reg.×4
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