CDER Patient-Focused Drug Development
Upcoming Public Webinar
On September 9, 2022, the U.S. Food and Drug Administration (FDA) is hosting a webinar for industry and other interested stakeholders to discuss and answer questions about the draft guidance: Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.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.
For more information, and to register for the webinar, please click here.
Meeting Recordings Available: Using Methods from PFDD Guidance 1 and Guidance 2 as Tools for Including Patient Experience Data in Clinical Trials Public Meetings
On June 30, 2022 and July 25, 2022, FDA hosted a series of public meetings.
Meeting #1 (June 30, 2022)
Speakers and participants discussed a range of issues and best practices related to collecting patient input, selecting data collection methods, and developing sampling plans and strategies. External stakeholders presented examples of how they have used the guidance documents as tool to inform their collection of patient data.
To view the meeting recording and materials, please click here.
Meeting #2 (July 25, 2022)
Speakers and participants discussed a range of issues related to data collection and analysis, focusing on lessons learned and on areas identified as particularly challenging for stakeholders. External stakeholders presented examples of how they have used the guidance documents as tool to inform their collection of patient data.
To view the meeting recording and materials, please click here.
Externally-led Patient-Focused Drug Development Meetings Webpage
FDA recently updated the Externally-led Patient-Focused Drug Development (EL-PFDD) Meetings webpage.
The webpage update includes:
- An overview of the EL-PFDD Program
- An updated webpage with information on planning an EL-PFDD meeting
- A new webpage containing a list of disease areas where a letter of intent (LOI) has been submitted and ongoing plans exist for a future Externally-Led PFDD meeting
For more information, please click here.
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