As part of FDA’s commitments under the Prescription Drug User Fee Act reauthorization of 2012, FDA has taken several steps to inform assessment of benefit-risk in CDER’s Patientsregulatory decisions concerning new drugs. The Patient-Focused Drug Development (PFDD) initiative is part of FDA commitments under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V).  The PFDD initiative aims to more systematically obtain the patient perspective on specific diseases and their treatments.

The patient perspective is critical in helping FDA understand the context in which regulatory decisions are made for new drugs. PFDD meetings give FDA an important opportunity to hear directly from patients, patient advocates, and caretakers about the symptoms that matter most to them, the impact the disease has on patients’ daily lives, and patients’ experiences with currently available treatments. This input can inform FDA’s decisions and oversight both during drug development and during our review of a marketing application.

Topics covered:

  • What is the opportunity for an externally-led PFDD meeting?
  • How might FDA participate in an externally-led meeting?
  • What should stakeholders consider when deciding to pursue an externally-led meeting?
  • How can stakeholders contact the FDA regarding their interest to conduct an externally-led PFDD meeting?
  • How can stakeholders plan and prepare for an externally-led PFDD meeting?
  • What are some valuable meeting deliverables?
  • Where can stakeholders find resources to use in preparation for the externally-led PFDD meeting?

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