Does clinical investigation of a marketed drug or biologic always require an IND submission?

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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.

About the Author
Proxima CRO Team
Ellie Reynolds
Quality Assurance

Ellie Reynolds is from Dallas, Texas and is a Quality Assurance and Regulatory Affairs Associate for Proxima. She just completed her M.B.E. in Bioengineering at Rice University and previously received her B.E. in Biomedical Engineering from Vanderbilt University. Prior to completing her master's degree, she worked in strategy consulting for biotech and pharma companies and is eager to combine her educational background and professional experience in this role.  

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