A father's plea: The FDA needs to make sure that Juno's lethal disaster isn't repeated
The FDA never has publicly explained just why it decided to lift a clinical hold on Juno’s lead CAR-T drug JCAR015 just days after the stunning news that the trial was being halted after three patients taking the cell therapy died of a cerebral edema. But then, it never does, citing secrecy rules that frequently keep regulators silent.
Now the father of one of those victims has joined in a petition from the Center for Responsible Science seeking some real transparency at the FDA on the way it handles patient deaths — with major implications for the people who participate in clinical trials.
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