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Patient-Focused Drug Development: A New Direction for Collaboration.

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      Abstract

      Patient-Focused Drug Development (PFDD) is a new initiative from the Food and Drug Administration (FDA) intended to bring patient perspectives into an earlier stage of product development. The goal is that patients will be able to provide context for benefit-risk assessments and input to review divisions, and also aid in the development of new assessment tools, study endpoints, and risk communications. This paper provides a summary on what is known to date about FDA's PFDD initiative and describes implications for patients, researchers, payers, and the biopharmaceutical industry. It also provides a roadmap for stakeholders to consider in defining their role in and in shaping PFDD's direction, and for expanding PFDD principles to conditions beyond the current 20 under FDA consideration.

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      Affiliations
      [1 ] *Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD †LORA Group LLC, Royal Oak, MD ‡Epstein Health LLC, Woodcliff Lake, NJ.
      Journal
      Med Care
      Medical care
      1537-1948
      0025-7079
      Jan 2015
      : 53
      : 1
      10.1097/MLR.0000000000000273 00005650-201501000-00003 25494232

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