The process must begin with your healthcare provider, who should follow these steps:
- Your healthcare provider must contact the company that manufactures the drug to make sure it is willing to provide the drug.
- Your healthcare provider must submit an Investigational New Drug (IND) [link to section below] application to the appropriate FDA review division.
- In an emergency situation, the request to use the drug may be made via telephone or other rapid means of communication, and authorization to ship and use the drug may be given by the FDA official over the telephone. With emergency INDs, shipment of and treatment with the drug may begin prior to FDA’s receipt of the written IND submission that is to follow the initial request.
- In a nonemergency situation, the IND must be received by FDA before shipment of and treatment with the drug may begin. These nonemergency requests are known as individual patient INDs.