Janet Woodcock is spearheading a legislative push to establish a third way for rare disease drug developers to meet the Food, Drug, and Cosmetic Act’s “substantial evidence” standard, which could be one of the most dramatic transformations to the drug approval process since Congress first mandated drugs be shown to be effective as well as safe in 1962.
Woodcock Throws Weight Behind Push For New Legislative ‘Substantial Evidence’ Standard For Rare Disease Drugs
Woodcock and the Haystack Project want to modify a foundational concept of modern FDA drug efficacy assessments, which may be seen as an attempt to more formally codify and define regulatory flexibility.
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