Discover and read the best of Twitter Threads about #DyingWaiting
Most recents (1)
As a physician, I support the FDA's role in protecting patients from adverse events, ensuring safety & efficacy.
As a physician living with #ALS, I've recognized there must be different regulatory flexibility for untreatable lethal diseases.
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As a physician living with #ALS, I've recognized there must be different regulatory flexibility for untreatable lethal diseases.
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As a physician who was denied access to clinical trials for 8 yrs, I have been #DyingWaiting for some drug, any drug, with some efficacy to be approved.
I have been horrified by the FDA's regulatory rigidity & inhumanity toward the ALS community.
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I have been horrified by the FDA's regulatory rigidity & inhumanity toward the ALS community.
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After multiple meetings, a new #ALS Guidance Document in 2019, and a flawed subjective tool to evaluate efficacy as a trial endpoint, the FDA has refused to honor its promise to exercise regulatory flexibility in recognition of the "critical unmet need."
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