FDA Request for Feedback: Patient Focused Drug Development Meetings
The FDA recently put out a request for information for feedback (RFI) from patient organizations, medical product developers, healthcare providers, academic researchers, and other stakeholders with firsthand experience regarding the impact of Patient-Focused Drug Development (PFDD) meetings.
In June 2024, Myositis Support and Understanding (MSU) in collaboration with The Myositis Association (TMA), convened an Externally-Led Patient-Focused Drug Development Meeting(EL-PFDD) on Adult Dermatomyositis. This meeting brought together patients, caregivers, clinicians, and FDA representatives to capture the lived expereince of individuals with Dermatomyositis (DM) and to identify key unmet needs in treatment, clinical care, and research.
The attached document underscores the impact of the Voice of the Patent Report as a living scientific and advocacy resource and how MSU has integrated its findings into our research initiatives. MSU also suggests recommendations to the FDA to further enhance the impact of EL-PFDD efforts that include:
- Recognizing EL-PFDD outputs as durable evidence resources
- Encouraging sponsors to incorporate EL-PFDD findings early in development
- Supporting secondary analysis of EL-PFDD datasets
- Promoting integration with patient registries
- Recognizing patient organizations as data stewards
