December Update on PDUFA and MDUFA
The U.S. Food and Drug Administration (FDA) held two meetings this month 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. Cynthia Bens and Ryne Carney represented ACT-AD 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.