Outcomes of Interest for Regulatory Science Research Projects
Note that it is expected that projects will achieve multiple outcomes of interest, and that they will be on different time scales.
- Foundational Requirements for Regulatory Science Research Projects
- Identify how the collaboration will enhance FDA resources/ expertise/ capability
- Identify unmet need or regulatory science challenge to be addressed
- Specify which area of regulatory science the project falls under within FDA’s Regulatory Science Framework:
- Modernize Development and Evaluation of FDA-regulated Products
- Strengthen Post-market Surveillance and Labeling of FDA-regulated Products
- Invigorate Public Health Preparedness and Response of the FDA, Patients and Consumers
- Disseminate Scientific Knowledge
- To FDA
- Final report on project results/ outcomes
- Presentations to FDA staff or at FDA workshop
- Training for FDA staff
- To Scientific Stakeholders
- Publish relevant methods/outcomes/ results in peer-reviewed journals(s) and citations in literature (Aim for open-access journals)
- Present at scientific/clinical conferences/ workshops
- Data-sharing via publicly available platforms/ databases
- Incorporate relevant methods/outcomes into training and/or education curriculum
- Media coverage for the Public
- CERSI initiated
- FDA initiated
- Outside source
- Trade press (e.g., medical periodical)
- Lay press (e.g., news outlet)
- To FDA
- Catalyze Action Among Relevant Stakeholders
- Create partnership with expert groups/ stakeholders to collaborate on project and achieve regulatory science outcomes of interest
- Enhance communication with expert groups/ stakeholders/ patients/ consumers to raise awareness of project outcomes
- Industry utilizes relevant methods/outcomes (e.g., tool submission)
- Industry uses regulatory science outcome in premarket submission
- Patient and/or consumer groups utilize relevant methods/outcomes
- Technology transfer to stakeholders
- Relevant methods/outcomes subject of professional meeting
- Relevant methods/outcomes subject of FDA public meeting
- Catalyst for future research funding
- Inclusion into clinical practice or other relevant medical guidelines
- Inform Regulatory Decision Making
- Present at FDA Advisory Committee
- FDA utilizes relevant methods/outcomes (in regulatory submission)
- Development or change in Guidelines/guidance
- Development of change in regulations
- Development or change in Reference materials
- Development or change in Consensus standards
- Development or change in Surveillance strategies
- Development or change in Compliance/ enforcement strategies
- Development or change in Inspection/sampling strategies
- Development or change in External communication strategies
- Development or change in Labeling
- Development or change in Agency policy
- Other