On December 18th, FDA is conducting a public workshop to convene a discussion on methodological approaches that a person seeking to collect patient experience data for submission to FDA to inform regulatory decision-making may use. The workshop will focus on topics related to approaches to collecting comprehensive and representative patient and caregiver input on burden of disease and current therapy. This workshop will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act and to meet a performance goal included in the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI).
The purpose of this public workshop is to obtain feedback from stakeholders on consideration for:
- Standardized nomenclature and terminologies for patient-focused drug development
- Methods to collect meaningful patient input throughout the drug development process
- Methodological consideration for data collection, reporting, management, and analysis of patient input
FDA is seeking information and comments from a broad range of stakeholders, including patients, patient advocates, academic and medical researchers, expert practitioners, drug developers and other interested persons. FDA will publish a discussion document approximately one month before the workshop date and is interested in seeking information and comments on the approaches proposed in the discussion document.
This website will be updated as workshop materials are developed.
Monday, December 18, 2017
9:00 a.m. – 5:00 p.m.
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31, Room 1503 (Great Room)
Silver Spring, MD 20993
(Information about arrival to FDA’s White Oak campus)
To register for this meeting, visit: pfdd.eventbrite.com .
Registration will close on December 10, 2017.
If you are unable to attend the workshop in person, you can register to view a live webcast of the workshop. You will be asked to indicate in your registration if you plan to attend in person or via the webcast. Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis. However, FDA may limit the number of participants from each organization based on space limitations. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the workshop will be based on space availability.
Patient-Focused Drug Development Guidance 1 - December 2017
The webcast will begin streaming approximately one hour before the start of the meeting. A recording of the webcast as well as a transcript will be available on this workshop website approximately one month after the workshop takes place.
In addition to providing input at the public workshop, stakeholders are invited to submit comments through the public docket. The public docket will close on February 16, 2018.
- Workshop Agenda (PDF - 279 KB)
- Discussion Document (PDF - 1.0 MB)
- Attachment to Discussion Document: Appendices (PDF - 698 KB)
- Attachment to Discussion Document: Draft Standardized Nomenclature and Terminologies for the Series of FDA PFDD Guidances (Glossary) (PDF - 244 KB)
- Federal Register Notice
- Meeting Slldes: Patient-Focused Drug Development Collecting Comprehensive and Representative Input December 18, 2017
- Meeting Recordings: