Public Workshop on Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data
On March 19th, FDA is conducting a public workshop to convene a discussion on how a person seeking to develop and submit proposed draft guidance relating to patient experience data for consideration by the FDA may submit such proposed draft guidance to the Agency. This workshop will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act.
The purpose of this public workshop is to obtain input from stakeholders on considerations for development and submission of proposed draft guidance relating to patient experience data submitted by an external stakeholder, including:
- Defining the scope of the proposed draft guidance
- Developing the proposed draft guidance
- Submitting the proposed draft guidance to the FDA
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 background document approximately two weeks before the workshop date.
This website will be updated as workshop materials are developed.
Monday, March 19, 2018
1:00 p.m. – 5:00 p.m. (registration will begin at 12pm)
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: Eventbrite Registration
Registration to attend in person will close on March 12, 2018.
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 - March 2019
The webcast will begin streaming approximately one hour before the start of the workshop. 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 May 18, 2018.
- Meeting Transcript (PDF - 923 KB)
- Meeting Slides (PDF - 1 MB)*
- Meeting Recording 1
- Meeting Recording 2
- Federal Register Notice
- Agenda (PDF - 206KB)
- Background Document (PDF - 183 KB)
* Persons with disabilities having problems accessing the PDF file(s) below may call (301) 796-3634 for assistance.