- September 9, 2022
- 12:00 PM - 3:00 PM ET
On September 9, 2022, the U.S. Food and Drug Administration (FDA) hosted a webinar for industry, patient groups, and other interested stakeholders to discuss and answer questions about the draft guidance: Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.
Guidance 3 is the third in a series of four methodological patient-focused drug development (PFDD) guidance documents that describe how stakeholders (patients, caregivers, researchers, medical product developers, and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making. Guidance 3 discusses approaches to selecting, modifying, developing, and validating clinical outcome assessments to measure outcomes of importance to patients in clinical trials.
Public Docket: Interested stakeholders are invited to submit comments on the draft guidance to the public docket. The public docket will close on September 28, 2022.
|PFDD Guidance 3 Public Webinar Slides||pdf (4.42 MB)|