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The investigational use of approved, marketed products differs from the situation described above. "Investigational use" suggests the use of an approved product in the context of a clinical study protocol [see 21 CFR 312.3(b)]. When the principal intent of the investigational use of a test article is to develop information about the product's safety or efficacy, submission of an IND or IDE may be required. However, 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 certain conditions are met. In its review of the project, the IRB will determine 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;
- It is conducted in compliance with the requirements concerning the promotion and sale of drugs; and
- It does not intend to invoke the exception for informed consent requirements (21 CFR 50.24).