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Biomarker Qualification 2.0: Cures Act, User Fees Will Enhance FDA Pathway

 
• By Michael McCaughan

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.

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.

The 21st Century Cures Act made some small but potentially significant changes to FDA’s process for reviewing Biomarker “Qualification” requests – and the results should be a more “proactive” approach...

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