Confluence of Symptoms and Treatments at FDA Patient Meetings
This article was originally published in RPM Report
The first round of four PDUFA patient-focused meetings concluded with the Sept. 24 meeting on narcolepsy. FDA is beginning to look ahead to the fiscal 2014 meetings – to start with fibromyalgia on December 10. One pattern that is emerging is that three of the first five conditions discussed with patients have overlapping symptoms and treatments.
You may also be interested in...
FDA recently announced a significant step in furthering the development of patient-reported outcomes: the planned creation of a web-based compendium of clinical outcomes assessments, including PROs. But an even more significant sign that FDA is committed to developing new patient-reported endpoints came directly from reviewers – including some divisions that have not historically been out front on the issue.
FDA has selected CFS/ME as the first topic for the PDUFA V patient-centered drug development initiative. The lessons learned from this session will inform future work on patient engagement in drug development both for FDA—and for patient advocates.
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.