Biomarker Qualification Costs As Much As Application Review, FDA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Agency’s cost estimate for implementing 21st Century Cures bill seems in part a call for user fees.
You may also be interested in...
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.
Congressional ‘Cures’ Debate Shifts To FDA Funding
House Democrats say FDA will need more money to be able to handle the responsibilities in the draft bill, while the agency worries reviews could slow without more resources.
After ‘Clean’ User Fee Renewal, Will Programs Held Hostage Be Enough To Drive A Broader Reform Bill?
Continuing resolution will force lawmakers back to the bargaining table before year end. Orphan grants and pediatric exclusivity are among the programs left out of the short-term spending measure as Congressional Democrats seek leverage to add more policy riders.