4 ms·
you can get approval on a case by case basis, from what I understand. The doctor or institution will have to send a letter to the FDA beforehand though.
by epmaybe 9y ago
you can get approval on a case by case basis, from what I understand. The doctor or institution will have to send a letter to the FDA beforehand though.
- refurb 9y agoThere is no need for physicians to inform the FDA about off-label use. It happens thousands of times per day.
- epmaybe 9y agoI think when I wrote this comment I forgot what we were talking about. I was thinking about drugs currently being used in clinical trials. My mistake
- refurb 9y agoYou are correct about the compassionate use/early access program where patients take drugs prior to FDA approval. All of that needs to be done in concert with the FDA.