According to 21 CFR 312.2(b)(1), the clinical investigation of a marketed drug or biologic does not require submission of an IND if all six of the following conditions are met:
- It is not intended to be reported to FDA in support of a new indication for use or to support any other significant change in the labeling for the drug;
- It is not intended to support a significant change in the advertising for the product;
- It does not involve a route of administration or dosage level, use in a subject population, or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product;
- It is conducted in compliance with the requirements for IRB review and informed consent (21 CFR parts 56 and 50,respectively);
- It is conducted in compliance with the requirements concerning the promotion and sale of drugs (21 CFR 312.7); and
- It does not intend to invoke 21 CFR 50.24.
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