Should be one of these reasons found in 21 CFR 312.42
§ 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—(1) Clinical hold of a Phase 1 study
under an IND. FDA may place a proposed or ongoing Phase 1 investigation on clinical hold if it finds that:
(i) Human subjects are or would be
exposed to an unreasonable and significant risk of illness or injury;
(ii) The clinical investigators named
in the IND are not qualified by reason
of their scientific training and experience to conduct the investigation described in the IND;
(iii) The investigator brochure is
misleading, erroneous, or materially
incomplete; or
(iv) The IND does not contain sufficient information required under
§312.23 to assess the risks to subjects of
the proposed studies.
(v) The IND is for the study of an investigational drug intended to treat a
life-threatening disease or condition
that affects both genders, and men or
women with reproductive potential
who have the disease or condition
being studied are excluded from eligibility because of a risk or potential
risk from use of the investigational
drug of reproductive toxicity (i.e., affecting reproductive organs) or developmental toxicity (i.e., affecting potential offspring). The phrase ‘‘women
with reproductive potential’’ does not
include pregnant women. For purposes
of this paragraph, ‘‘life-threatening illnesses or diseases’’ are defined as ‘‘diseases or conditions where the likelihood of death is high unless the course
of the disease is interrupted.’’ The clinical hold would not apply under this paragraph to clinical studies conducted:
