An IRB Infoshort August 2013 IND 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 effectiveness ID: 616671
Download Presentation The PPT/PDF document "IND Determinations" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
Slide1
IND Determinations
An IRB
Infoshort
August 2013Slide2
IND
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 effectiveness.
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)Slide3
Approved Drugs—New Uses
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
populationSlide4
Approved drugs—New Uses
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 populationSlide5
IRB Determination
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. Slide6
IND and THE HIC APPLICATION
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)Slide7
Exemptions from IND filing
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. Slide8
IND Exemptions
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 submissionSlide9
IND ExemPtion
and the IRB
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)Slide10
Investigational Devices
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.