IND Application Procedures: Clinical Hold

A clinical hold is an order issued by FDA to the sponsor of an IND application to delay a proposed clinical investigation or to suspend an ongoing investigation. All or some of the investigations conducted under an IND application may be placed on clinical hold.

This page describes grounds and procedures for imposition of clinical hold for clinical investigations that are not subject to exceptions from the informed consent regulations 21 CFR 50.23(d) and 21CFR 50.24. For the grounds for clinical hold imposition related to clinical investigations that are subject to exceptions from informed consent regulations refer to 21 CFR 312.42b(5) and (6).

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 given the investigational drug; patients already in the study are expected to be taken off therapy involving the investigational drug unless treatment continuation is specifically permitted by FDA in the interest of patient safety.