part_subject: "INVESTIGATIONAL NEW DRUG APPLICATION"
subpart_code: "B"
subpart_subject: "Investigational New Drug Application (IND)"
section_number: "312.38"
section_subject: "Withdrawal of an IND."
cfr_reference: "21 CFR 312.38"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 300 to 499"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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(b)If an IND is withdrawn, FDA shall be so notified, all clinical investigations conducted under the IND shall be ended, all current investigators notified, and all stocks of the drug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(c)If an IND is withdrawn because of a safety reason, the sponsor shall promptly so inform FDA, all participating investigators, and all reviewing Institutional Review Boards, together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.