FDA BRIEF: Week of September 11, 2017


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FDA is Advancing the Goals of the Orphan Drug Act

By: Scott Gottlieb, M.D., FDA Commissioner

Orphan Drug Modernization Plan

  • eliminate a backlog of about 200 orphan drug designation requests t
  • pursue policies better advance the goals of the Orphan Drug Act (ODA).

Process improvements for review efficiency

  • Reorganization to leverage expertise across FDA’s medical product centers
  • New workflow to eliminate redundancies and delays

New policy steps for incentives

  • Hold public meeting on complex scientific and regulatory issues and appropriate orphan incentives
  • Examine aspects of granting designations to meet goals intended by Congress
  • Issue guidance documents to address loopholes for avoiding pediatric studies

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 “Continuous Manufacturing” – Common Guiding Principles Can Help Ensure Progress

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Priority Therapeutic Areas for Development

Standardizing study data specific to therapeutic areas (TAs) facilitate evaluation of medical products

  • Prioritization of TAs based on (1) areas of particular medical need, (2) areas with existing data standardization projects underway, and (3) areas with greater drug development pipeline activity
  • New roadmap for TAs in priority groupings
  • Collaboration of FDA, CDISC, Critical Path Institute, HL7’s Clinical Interoperability Council to define related clinical concepts

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Image credits: FDA

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