What are the requirements if a physician decides to use a product for an indication not in the approved labeling when the intent is the practice of medicine?

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Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. Physicians have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects if they choose to use a product for an indication not in the approved labeling. Use of a marketed product in this manner when the intent is the "practice of medicine" does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB). However, the institution at which the product will be used may, under its own authority, require IRB review or other institutional oversight.

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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