Many academic investigators will want to conduct a clinical study with an already approved drug. This is often done to establish efficacy in a new disease indication. FDA provides provisions for conducting studies of lawfully marketed drugs through the use of an IND exemption. A clinical investigation of a drug is exempt from the IND requirements if all of the criteria for an exemption in 21 CFR 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;
- The investigation is not intended to support a significant change in advertising to an existing lawfully marketed prescription drug product;
- The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product;
- The investigation will be conducted in compliance with the requirements for institutional review set forth in FDA regulations 21 CFR 56, and requirements for informed consent as set forth in FDA regulations 21 CFR 50;
- The investigation will be conducted in compliance with FDA regulations 21 CFR 312.7: Promotion of investigational drugs.
FDA Guidance: Investigational New Drug Applications (INDs) – Determining whether Human Research Studies can be conducted without an IND.
The Office for Research Protections Quality Assurance Program can help investigators determine whether or not an IND is needed. Contact them at orp-qm@psu.edu.
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