Lawmakers Praise MDUFA For Faster Approvals, FDA Plugs Planned Patient Engagement

Lawmakers and stakeholders highlighted the successes of the medical device user fee program in speeding up FDA's review of devices, during a Tuesday (March 28) House Energy & Commerce hearing on reauthorization of the Medical Device User Fee Amendments (MDUFA). FDA's device center chief also emphasized the impact the new agreement, if ratified as written, would have on further incorporating the patient perspective into FDA's review processes, and supporting the National Evaluation System for health Technology (NEST) program. Despite scrutiny...