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A December Update on PDUFA and MDUFA

December 22, 2015   |   Alliance for Aging Research Team   |   FDA & Regulatory Policy
Open prescription bottles with pills spilling out.

The Alliance has been very active in ongoing activities surrounding the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA). As we head into the new year, here’s an update on the latest.

The U.S. Food and Drug Administration (FDA) held two meetings in December with representatives from patient and consumer advocacy organizations to discuss progress in its negotiations with industry on the sixth reauthorization of the prescription drug user fee program and the fourth reauthorization of the medical device user fee program.

Vice President of Public Policy Cynthia Bens and Public Policy Assistant Ryne Carney represented the Alliance at both of these meetings.

In prepared remarks, Bens called for the expansion of existing mechanisms at FDA’s Center for Drug Evaluation and Research to encourage greater patient and caregiver input into endpoint development as part of PDUFA VI. Bens also focused on the need for additional staff at the Center for Devices and Radiological Health through MDUFA IV to evaluate patient-reported outcome data and other patient preference information.

These prepared remarks can be found here for PDUFA and here for MDUFA.

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