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FDA Adds “Consultation Meetings” To Patient-Focused Drug Development Effort

 
• By Sue Sutter

The agency is seeking patient community input on process issues related to holding 20 meetings on disease-specific areas over the next five years under PDUFA V. FDA has proposed 39 medical conditions that could be considered for those disease-specific meetings.

FDA is seeking patient community input on several process topics related to patient-focused drug development meetings required under PDUFA V, including how to approach issues when representatives for the same disease have different and potentially conflicting views.

The agency is convening a series of periodic consultation meetings with patient stakeholders to discuss challenges in developing a process for conducting patient-focused meetings under the recently reauthorized Prescription Drug User Fee Act

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