GroundRules
21 CFR 312.38: Withdrawal of an IND.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER D—DRUGS FOR HUMAN USE
- PART 312—INVESTIGATIONAL NEW DRUG APPLICATION
- Subpart B—Investigational New Drug Application (IND)
(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(b) If an IND is withdrawn, FDA shall be so notified, all clinical investigations conducted under the IND shall be ended, all current investigators notified, and all stocks of the drug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(c) If an IND is withdrawn because of a safety reason, the sponsor shall promptly so inform FDA, all participating investigators, and all reviewing Institutional Review Boards, together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.
Collected 2026-08-27T02:24:47Z. Source file · JSON