Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.42

Document information
Reference	USA 21 CFR Part 312 09-Apr-2025
Validity area	USA
Scope(s)	HM
Document name	21 CFR Part 312
Version / Revision	09-Apr-2025
Status	Current
Document type	Legal act
Language(s)	EN
Description	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 https://www.ecfr.gov/current/title-21
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 6 — Unit 6.1.2
Scope	HM
Document part	§ 312.42
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Temporary halt, Safety, Investigational drug (IMP), FDA, Sponsor
Comment	Clinical hold: grounds and FDA authority

Content

§ 312.42 Clinical holds and requests for modification. (a) General. A clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. The clinical hold order may apply to one or more of the investigations covered by an IND. When a proposed study is placed on clinical hold, subjects may not be given the investigational drug. When an ongoing study is placed on clinical hold, no new subjects may be recruited to the study and placed on the investigational drug; patients already in the study should be taken off therapy involving the investigational drug unless specifically permitted by FDA in the interest of patient safety.

(b) Grounds for imposition of clinical hold — [...] (c) Discussion of deficiency [...] (d) Imposition of clinical hold [...] (e) Resumption of clinical investigations An investigation may only resume after FDA (usually the Division Director, or the Director's designee, with responsibility for review of the IND) has notified the sponsor that the investigation may proceed. Resumption of the affected investigation(s) will be authorized when the sponsor corrects the deficiency(ies) previously cited or otherwise satisfies the agency that the investigation(s) can proceed. FDA may notify a sponsor of its determination regarding the clinical hold by telephone or other means of rapid communication. If a sponsor of an IND that has been placed on clinical hold requests in writing that the clinical hold be removed and submits a complete response to the issue(s) identified in the clinical hold order, FDA shall respond in writing to the sponsor within 30-calendar days of receipt of the request and the complete response. FDA's response will either remove or maintain the clinical hold, and will state the reasons for such determination. Notwithstanding the 30-calendar day response time, a sponsor may not proceed with a clinical trial on which a clinical hold has been imposed until the sponsor has been notified by FDA that the hold has been lifted.

(f) Appeal [...] (g) Conversion of IND on clinical hold to inactive status [...]