On October 24th, FDA is conducting a public workshop on Erythropoietic Protoporphyria (EPP). EPP is a group of genetic disorders that is characterized by photosensitivity that often manifests as severe pain, swelling and/or burning. The public workshop is intended to discuss how best to facilitate and expedite the development of safe and effective drug therapies to treat signs and symptoms related to EPP. FDA will provide information for and gain perspective from patients and patient advocacy organizations, health care providers, academic experts, and industry on disease symptoms and its impact on daily life, experience with current treatment regimens for EPP, and various aspects of clinical development of products intended to treat EPP. The input from this public workshop will help in developing topics for further discussion.
This website will be updated as workshop materials are developed.
Monday, October 24, 2016
10:00 a.m. – 4:00 p.m.
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31, Room 1503A (Great Room)
Silver Spring, MD 20993
(Information about arrival to FDA’s White Oak campus))
To register for this meeting, visit: http://eppscientificworkshop.eventbrite.com
Registration will close on October 17, 2016.
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.
In addition to providing input at the public meeting, patient stakeholders are invited to provide their perspectives on the discussion questions through the public docket. The docket closes on December 24, 2016.
Visit the Public Docket to submit your comment.