Investigational New Drug (IND) Requirements
An Investigational New Drug (IND) application is submitted to the FDA if a drug (or biological product) not previously authorized for marketing in the US is intended to be used for the purposes of clinical investigation or, in certain cases, for the purposes of clinical treatment when no approved therapies are available. Whether an IND is needed to conduct a clinical Investigation of a marketed drug primarily depends on the intent of the investigation and the degree of risk associated with the use of the drug in the investigation.
Additionally, when an IND is required, the study must be conducted in compliance with 21 CFR 312.7, which deals with the promotion and sale of investigational products. IND exempt studies must comply with informed consent and IRB approval requirements (21 CFR 50 and 56, respectively). If a study does not require an IND per the FDA, the investigator must be able to document this determination, and the Institutional Review Board (IRB) will verify documentation.
An IND is required when all of the following conditions exist (21CFR 312):
The research involves a drug as that term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(g)(1)).
The research is a clinical investigation as defined in the IND regulations (21 CFR 312.3).
The clinical investigation is not otherwise exempt from the IND requirements in part 312 (see section IV of this guidance).
A clinical investigation of a marketed drug is exempt from the IND requirements if all of the criteria for an exemption in § 312.2(b) are met:
The drug product is lawfully marketed in the United States.
The investigation is not intended to be reported to FDA as a well-controlled study in support of a new indication and there is no intent to use it to support any other significant change in the labeling of the drug.
In the case of a prescription drug, the investigation is not intended to support a significant change in the advertising for the drug.
The investigation does not involve a route of administration, dose, patient population, or other factor that significantly increases the risk (or decreases the acceptability of the risk) associated with the use of the drug product (21 CFR 312.2(b)(1)(iii)).
The investigation is conducted in compliance with the requirements for review by an IRB (21 CFR part 56) and with the requirements for informed consent (21 CFR part 50).
The investigation is conducted in compliance with the requirements of § 312.7 (i.e., the investigation is not intended to promote or commercialize the drug product).
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