Hello everyone.
I'm new to this forum. I would like to post some questions that is related to regulations and amendments of pharmacutical researches. If any kind person can help me in finding the answers would be really thankful.

Q- Assume you have a patient with a terminal illness who tells you he/she wants to buy a drug outside the US and have it shipped to the US even though it is not approved in the US and would like you to oversee their care while on this drug. What communication and approval process would you as the physician need to have with the FDA? What regulations guide you through this process?