Biomarker Qualification 2.0: Cures Act, User Fees Will Enhance FDA Pathway
US agency will be more 'proactive' in engaging with outside groups interested in using the biomarker qualification process using the new resources and directives of the 21st Century Cures Act and the pending Prescription Drug User Fee Act reauthorization.
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Final version of Cures legislation combines several aspects of initial House and Senate legislation, and also includes some completely new elements.