Monday, February 19, 2018 5:08:47 PM
The FDA has two programs for compassionate use.
The original version: Individual INDs.
This allows somebody to file with the FDA to treat the single patient. Flexible, but obviously paperwork is a bot of a bitch
The newer (circa 2007?) version: Expanded Access:
The company files a single IND with the FDA that covers patients meeting certain requirements. Once the FDA approves this, and patient meeting the requirements can be treated.
The current compassionate access arm that was being discussed is listed in clinical trials here
I do agree with you that there look to be some patients treated on the "individual" program. And I have no clue how it works ex-us
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