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  1. Advancing Regulatory Science

Outcomes of Interest for Regulatory Science Research Projects

The foundational requirements for Regulatory Science Research Projects are to enhance FDA resources, expertise, and capability and fulfill an unmet need or regulatory science challenge. Projects should fall under an area within FDA’s Regulatory Science Framework.

Below are the potential outcomes for regulatory science research projects. It is expected that projects will achieve multiple outcomes of interest, and that they will be on different time scales.

  1. Disseminate Scientific Knowledge
    1. To FDA
      1. Final report on project results/ outcomes
      2. Presentations to FDA staff or at FDA workshop
      3. Training for FDA staff
    2. To Scientific Stakeholders
      1. Publish relevant methods/outcomes/ results in peer-reviewed journals(s) and citations in literature (Aim for open-access journals)
      2. Present at scientific/clinical conferences/ workshops
      3. Data-sharing via publicly available platforms/ databases
      4. Incorporate relevant methods/outcomes into training and/or education curriculum
    3. Media coverage for the Public
      1. CERSI initiated
      2. FDA initiated
      3. Outside source
        1. Trade press (e.g., medical periodical)
        2. Lay press (e.g., news outlet)
  2. Catalyze Action Among Relevant Stakeholders
    1. Create partnership with expert groups/ stakeholders to collaborate on project and achieve regulatory science outcomes of interest
    2. Enhance communication with expert groups/ stakeholders/ patients/ consumers to raise awareness of project outcomes
    3. Industry utilizes relevant methods/outcomes (e.g., tool submission)
    4. Industry uses regulatory science outcome in premarket submission
    5. Patient and/or consumer groups utilize relevant methods/outcomes
    6. Technology transfer to stakeholders
    7. Relevant methods/outcomes subject of professional meeting
    8. Relevant methods/outcomes subject of FDA public meeting
    9. Catalyst for future research funding
    10. Inclusion into clinical practice or other relevant medical guidelines
  3. Inform Regulatory Decision Making
    1. Present at FDA Advisory Committee
    2. FDA utilizes relevant methods/outcomes (in regulatory submission)
    3. Development or change in Guidelines/guidance
    4. Development of change in regulations
    5. Development or change in Reference materials
    6. Development or change in Consensus standards
    7. Development or change in Surveillance strategies
    8. Development or change in Compliance/ enforcement strategies
    9. Development or change in Inspection/sampling strategies
    10. Development or change in External communication strategies
    11. Development or change in Labeling
    12. Development or change in Agency policy
    13. Other
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