FDA Continues Monthly Stakeholder Consultation on PDUFA and MDUFA 

The FDA recently hosted the next in a series of meetings with patient and research advocacy groups to discuss the status of negotiations on the reauthorization of the prescription drug and medical device user fee programs. The MDUFA meeting held on October 26 provided an opportunity for CDRH representatives to highlight activities they have undertaken to improve representation of demographic subgroups in clinical trials.  The meeting also allowed FDA to have stakeholders identify their top priorities for the reauthorization of the medical device user fee program. These priorities include securing resources for CDRH to enhance patient preference activities, improving efficiency in pre- and post-marketing data collection, establishing a system for incorporation of patient registries and unique device identifiers, and enabling cross-center coordination on combination products and companion diagnostics. The PDUFA meeting on November 16 focused on the evolution of FDA’s Sentinel System for post-market surveillance and projects the agency is involved in to leverage data sources to confirm regulatory decisions. ACT-AD was represented by the Alliance for Aging Research during both discussions.