What happens if a for-profit firm claims they are doing RTT but don't follow the rules. Under the new law can FDA go after them & if not, who will?https://twitter.com/RAPSorg/status/1002282658964140032 …
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That's what I'm already hearing. They plan to claim RTT offerings, but won't even have IND
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Supposedly, to qualify for#RightToTry, a drug had to have passed phase I and have an active IND. However, that's a low bar. I could see unethical drug companies trotting out a bunch of abandoned drugs and getting INDs for RTT.
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