What are the rules regarding IRB review of Off Label Uses?
When the intent is the “practice of medicine” and a marketed product is used in a manner that is not approved in the labeling, the FDA does not require the submission of an Investigational New Drug Application, Investigational Device Exemption, or review by an Institutional Review Board. It is the physician’s responsibility to base off label use on firm scientific rationale and on sound medical evidence and to document the product’s use and effects. However, if the physician uses or plans to use data collected from off label use of an approved drug or device to prove or disprove an hypothesis, he or she must then follow the regulations and guidelines as put forth in the Code of Federal Regulations including obtaining FDA approval, and IRB approval.
Related Questions
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- What are the rules regarding IRB review of Off Label Uses?
