Biomarker Qualification Costs As Much As Application Review, FDA Says
This article was originally published in The Pink Sheet Daily
Agency’s cost estimate for implementing 21st Century Cures bill seems in part a call for user fees.
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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.
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.
US FDA proposed increasing staffing and resources for both programs during the next user fee program cycle, but industry representatives did not believe it necessary.