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  5. Expanded Access: Criteria for an Investigational Product to be Made Available For Widespread Use Under a Treatment Protocol or Treatment IND/ Treatment IDE
  1. Expanded Access

Expanded Access: Criteria for an Investigational Product to be Made Available For Widespread Use Under a Treatment Protocol or Treatment IND/ Treatment IDE

Under FDA’s statute, a sponsor or a physician may submit an expanded access request for widespread access to an investigational product if certain criteria are met:

  • The investigational product is intended for use in the diagnosis, monitoring, or treatment of a serious or immediately life-threatening disease or condition;
  • There is no comparable or satisfactory alternative therapy available to diagnose, monitor, or treat that stage of disease or condition in the relevant patient population;
  • The investigational product is being studied in a controlled clinical trial for the same use, under an IND or IDE or all clinical trials necessary for approval of that use have been completed;
  • The sponsor of the controlled clinical trials is actively pursuing, with due diligence, marketing approval, or clearance for the same use; 
  • If the investigational product is being studied in a controlled clinical trial, under an IND or IDE, providing the investigational product under a treatment IND or IDE will not interfere with the enrollment in the ongoing clinical investigation(s);
  • In the case of serious diseases, there is sufficient evidence of safety and effectiveness to support the use for the indication under the treatment IND or IDE; 
  • In the case of immediately life-threatening diseases, the available scientific evidence, taken as a whole, provides a reasonable basis to conclude that the investigational product may be effective for its intended use and would not expose patients to an unreasonable and significant risk of illness or injury.

Related Information:

Expanded Access (Compassionate Use) Main Page 

 
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