August 2024 SOCRA Source Journal - Journal - Page 37
Investigational New Drug
Application
The FDA received 618
Investigational New Drug (IND)
applications from October 2018
to September 2019 and 162
IND applications during the
昀椀rst quarter of 昀椀scal year 2020
(October 2019 to December
2019). In calendar year 2019,
the FDA received 12,328 IND
applications.
TABLE 4
Types of INDs
•
•
An IND application submission
is a request for an exemption
from the federal statute that
prohibits an unapproved
drug from being shipped in
interstate commerce. As per 21
CFR 312.22, the FDA’s primary
objectives in reviewing an
IND are to assure the safety
and rights of subjects in all
phases of the investigation,
and in Phase II and III, to help
ensure that the quality of the
scienti昀椀c evaluation is adequate
to permit an evaluation of the
drug’s effectiveness and safety.
An IND provides proof that the
product will not expose human
subjects to unreasonable risks
when used in limited, earlystage clinical trials.
•
•
•
Commercial IND:
o An IND for which the sponsor is usually a corporate entity
o The Center for Drug Evaluation and Research (CDER) may
designate other INDs as commercial if it is clear the sponsor
intends to commercialize the product later
Single Patient IND (Compassionate Use):
o When a patient is ineligible for enrollment in a Phase II/III
study but may bene昀椀t from the study drug
o Case-by-case approval
Treatment IND:
o After studies have established safety parameters and
early evidence of ef昀椀cacy, the investigational drug may
be approved to treat life-threatening illnesses where no
alternative therapy is available
Parallel Track Policy:
o After Phase I but before Phase II
o Provides access to the study drug for desperately ill patients
who have no other treatment options
o Permits wider access to promising new drugs for AIDS/
HIV-related diseases under a separate expanded access
protocol that parallels controlled clinical trials
o Expands the availability of drugs for treating AIDS/HIV
o Requires prospective IRB review and informed consent
Emergency Use IND:
o Use of an investigational drug in an emergency when time
for the usual IND submission is lacking
o FDA may authorize shipment of the drug for a speci昀椀ed use
(21 CFR 312.36):
-
Table 4 highlights the different
types of INDs:
o
•
Also, there are three broad
areas of focus in INDs:
•
•
•
•
Animal pharmacology and
toxicology studies
Manufacturing information
Clinical protocols and
investigator information.
The goals of FDA review of an
IND are to determine if the:
Prospective IRB review is required unless the conditions
for exemption are met (21 CFR 56.104(c) and 56.102(d))
Informed consent is required unless the conditions for
exception are met (21 CFR 50.23)
-
Commercial IND
Single Patient IND
Treatment IND
Parallel Track Policy
Emergency Use IND.
•
•
•
•
•
Usually conditioned upon the sponsor 昀椀ling an
appropriate application as soon as practical
Preclinical data show that the
drug is reasonably safe for
administration to humans
Protocol for the proposed
clinical studies will expose
subjects to undue risk.
The FDA’s Center for Drug
Evaluation and Research (CDER)
handles IND review. Within
CDER, the Of昀椀ce of Review
Management, Of昀椀ce of Drug
Evaluation, and 14 new drug
review divisions by therapeutic
area are involved in IND review.
Thus, reviewers have the
therapeutic area expertise and
experience to identify potential
risks or undue situations that
may occur. The FDA is given
only 30 days in which to reach
an initial decision on whether
the sponsor can move forward
with the study.
The FDA’s responses for an IND
application for Phase II or III are
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