3 ms·
>can the FDA actually stop or sanction experimental procedures like this? They explicitly permitted this operation, by means of https://www.fda.gov/news-events
by hprotagonist 5y ago
>can the FDA actually stop or sanction experimental procedures like this?
They explicitly permitted this operation, by means of https://www.fda.gov/news-events/public-health-focus/expanded-access https://www.fda.gov/news-events/public-health-focus/expanded...
Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.