Tuesday, October 1, 2024
10:00AM(ET) | Held Virtually on our Website
Externally Led Patient-Focused Drug Development Meeting
What is Patient-Focused Drug Development?
Patient-Focused Drug Development (PFDD) is a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation.
Watch the recording of this meeting below!
FDA’s Role in Medical Product Development
One of the FDA’s missions is to protect and promote public health by evaluating the safety and effectiveness of new drugs, biologics, and devices. FDA does not develop drugs nor conduct clinical trials. FDA does, however, play a constructive role in guiding, helping, or evaluating at some stages of the pre-clinical, translational, and clinical development at work.
Audience:
The key participants in PFDD meetings are patients, patient representatives, patient advocates, caregivers, loved ones, and anyone with a lived experience with the disease or condition. While patients and caregivers share their perspectives, key stakeholders are in listening mode as a part of the audience. This includes:
- The FDA and other regulatory/federal agencies
- Medical product developers
- Academic researchers
- Clinicians and healthcare professionals
It is important for all of these stakeholders to hear patient input as it may inform drug development. Aside from providing initial remarks from the FDA perspective, FDA staff participate as listeners in EL-PFDD meetings. The FA has been in support in the planning of this meeting.
Some host patient organizations choose to incorporate PFDD-style sessions as part of their annual conferences, scientific workshops, and other meetings. It is important to get patient input early in the drug development process.