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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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.
US FDA Holds First Hybrid Meeting With Industry
A Type A meeting was held in-person with a virtual contingent, the FDA clarified to the Pink Sheet. Several other meeting requests received were eligible, but did not seek an in-person session.