The Patient-Focused Drug Development Program Staff leads initiatives and provides strategic, regulatory, program, and policy assistance within the Center for Drug Evaluation and Research (CDER) to facilitate the incorporation of patient input into decision-making.
What We Do
- Design, develop, and implement programs to facilitate the incorporation of patient input into decision-making.
- Advise and support CDER and collaborate with other FDA Centers to advance the use and role of patient experience data in regulatory decision-making.
- Lead and manage Center activities related to patient-focused drug development provisions under the 21st Century Cures Act and the Food and Drug Administration Reauthorization Act (FDARA), which reauthorizes the Prescription Drug User Fee Act (PDUFA). This effort includes the development of a guidance series on the collection of patient experience data, and the use of such data and related information in drug development and decision-making.
- Initiate, plan and execute FDA-led patient-focused drug development meetings, and lead the data collection, analyses and summary report development for each meeting.
- Conduct a range of qualitative analyses to inform internal strategy and decision-making related to patient-focused drug development.
- Lead and manage FDA’s externally-led patient-focused drug development program.
- Develop and manage CDER’s External Resources or Information Related to Patients’ Experience pilot webpage.
- Conduct outreach and engage with external stakeholders to advance the integration of patient input into drug development and decision-making.
- Serve as CDER’s primary point of contact for patient-focused drug development activities.
- Advance the science of patient input through workshops, conferences and publications.
- CDER Patient-Focused Drug Development Homepage
- Patient-Focused Drug Development: Disease Area Meetings Held in Fiscal Years 2013-2017
- FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making
- Externally-led Patient-Focused Drug Development Meetings
- External Resources or Information Related to Patients’ Experience