A provisional drug approval pathway is needed for serious, life-threatening conditions that lack good biomarkers and cannot use the US Food and Drug Administration’s accelerated approval pathway, rare disease advocates said in urging Congress to pass the Promising Pathway Act.
Patients, advocacy group representatives and industry representatives who spoke at a 26 October Senate Aging Committee hearing, and at a press conference that preceded it, also said the legislation would help to ensure the US Food and Drug Administration consistently
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