Notice of Public Meeting on Patient-Focused Drug Development

The US Food and Drug Association will convene a public meeting and an opportunity for public comment on Patient-Focused Drug Development for neuropathic pain associated with peripheral neuropathies. The meeting will take place this Friday, June 10 from 10 am to 4 pm, and although the deadline for onsite attendance has expires, written or electronic comments are being accepted until August 10. The meeting is intended to provide patient perspective on neuropathic pain associated with peripheral neuropathies, including impact, treatment approaches and treatment selection decisions.

Patient-Focused Drug Development is an initiative that FDA undertakes in fulfillment of Agency performance commitments under the reauthorization of the Prescription Drug User Fee Act (PDUFA V). Neuropathic pain associated with peripheral neuropathies is one of 20 disease areas selected for investigation. The meeting will be structured around a predetermined set of topics and questions, each introduced by panel discussion and then opened to facilitated discussion with patients and patient stakeholder participants. These topics and question areas are outlined in the FDA meeting notice, which may be read, with instructions for submission of comments, here. A news story from The National Pain Report, with interesting commentary from Richard “Red” Lawhern, PhD, patient advocate and past board member of the Trigeminal Neuralgia Association, about his planned input to the meeting may be read here.


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