FDA's Patient-Centered Drug Center
This article was originally published in RPM Report
The new Prescription Drug User Fee Agreement includes a host of new projects, of varying potential impact. But it is clear that a plan to host a series of disease-specific meetings to identify key risk/benefit goals of patients is one of the most important from FDA’s perspective.
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The new Prescription Drug User Fee Act Program doesn’t take effect until October 1, but FDA has been getting moving on some key elements of the program since before the final negotiations began on Capitol Hill. FDA will need to move fast to meet the many policy deadlines set by the agreement negotiated with industry.
A stakeholder project on obesity treatment outcomes will complete its work this summer, setting the stage for FDA to rethink efficacy endpoints for weight loss drug development. The closed-door project is happening in parallel with public advisory committee discussions on pending applications and safety standards. One impact will be to shape more formal patient-centered drug development activities in years to come.
In the shadow of final negotiations over PDUFA reauthorization, the agency is inviting patients, their representatives, industry and academics to discuss how best to use patient input in decisions on regulated drugs, devices and biologics.