FDA has directed the sponsors of CAR T-cell therapies to place boxed warnings on their products to indicate that the agents may cause secondary T-cell malignancies.
After three weeks of brutal combat, Richard Pazdur decided that he has had enough.
FDA tells sponsors of CAR T-cell therapies to add boxed warning about secondary T-cell malignancies
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Vinay Prasad, FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, has instructed his staff to check with him before continuing to work on ongoing submissions to journals or beginning new contract-funded projects to “ensure that we are not engaging in sunk cost fallacy, not publishing obviously erroneous work, and not being distracted from our core mission.”
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