IND Determinations

An Investigational New Drug is a drug that has not yet been approved by the FDA for
marketing and is available only for use in research to determine safety and
All investigational drugs require an FDA IND number, signifying acceptance by the
FDA of an IND application for research.
The IND may be held by the sponsor (e.g. Pfizer), or by the researcher (the
academic sponsor investigator)
When research is proposed that involves use of an FDA-approved
drug for a new use, the researcher must determine whether or
not an IND is required. The HIC reviews this determination and
either concurs or not.
The IRB must consider whether the proposed use of the drug in the
research puts the subject population at greater risk from the
drug than the risk that is known for the FDA-approved population
Examples for consideration:
Use of an increased dose
Use of a different route of administration
Longer duration
Use in a vulnerable population
Use in a population where there is reason to believe the
population has different pharmacodynamic responses than the
indicated population
When the IRB has determined that an IND is not required, the IRB
minutes must indicate the following:
* the condition/disorder to be treated
* the variance from current FDA approval (e.g., different
indication or population)
* determination that the risks associated with its use in the
disorder/condition are not anticipated to be significantly
increased over known risks.
The HIC application requires that a drug, biologic or radiotracer not approved by, but
regulated by, the FDA, or a radiotracer regulated by the RDRC, provide the
following information:
* the IND number assigned by the FDA
* the name of the person/entity holding the IND
* For radiotracers regulated by the FDA but not approved them, the IND
number, OR
* Confirmation that the radiotracer is under RDRC/RSC oversight (where
an IND number is not required)
There are 4 exemptions from IND filing. The most common is category 1
The intention of the investigation is NOT to report to the FDA in support of a new indication
for use or to be used to support any other significant change in the labeling
The drug is lawfully marketed as a prescription drug product, and the intention of the
investigation is NOT to support a significant change in the advertising
The investigation does NOT involve a route of administration or dosage level or use in
populations or other factor that significantly increases the risks (or decreases the
acceptability of the risks) associated with the use of the drug.
The investigation will be conducted in compliance with the requirements for institutional
(HIC) review and with the requirements for informed consent of the FDA regulations
(21 CFR Part 50 and 21 CFR Part 56).
The investigation will be conducted in compliance with the requirements regarding
promotion and charging for investigational drugs.
Other categories:
In vitro study of a diagnostic biological product involving blood grouping serum,
reagent red blood cells or anti-human globulin, in a test intended to be used in a
diagnostic procedure confirming the diagnosis made by another medically
established diagnostic procedure or product .
Studies where the drug is intended solely for tests in vitro or in laboratory
research animals
A clinical investigation involving use of a placebo if the investigation doesn’t
otherwise require an IND submission
The IRB must review the investigator’s HIC application exemption
request and must agree with the exemption.
The correspondence to the investigator acknowledges this, and cites
the FDA exemption regulation, 21 CFR 312.2(b)
The FDA also has regulations concerning investigational devices (IDE)
These regulations mirror those of INDs.
There are specified exemptions
They require IRB determinations regarding need for an IDE, based on risk
They consider risk level: significant or non-significant
The determination that a device is non-significant does not mean that the
research is minimal risk
The HIC application includes specific questions and requirements for IDE
determination and also for YNHH review and approval.

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