Organize PDUFA V Patient-Focused Meetings Around Disease Clusters, Advocates Say
Patient groups urge FDA not to limit 20 meetings over the next five years to specific diseases, as the agency has proposed, but instead to take a broader view on diseases based upon similar characteristics, quality-of-life burden and available treatment options.
You may also be interested in...
Agency is undertaking a series of activities with patients, advocacy groups and other stakeholders aimed at spurring development of new treatments. Hemispherx is hoping its investigational drug Ampligen, currently under FDA review, will become an early beneficiary of new statutory provisions on expedited approval.
One day each will be devoted to eosinophilic esophagitis, pediatric and adult inflammatory bowel disease, and parenteral nutrition-associated liver disease, Sept. 19, 20, 21 and 24, in that order.
PDUFA V framework to involve patients in the creation of the risk-benefit criteria for various diseases kicks off before the legislation is even enacted.