Date: Monday, October 24th, 2016

Time: 10 am – 4 pm

Location: FDA White Oak Campus

10903 New Hampshire Ave.

Building 31, Great Room

Silver Spring, MD 20993

(Information about arrival to FDA’s White Oak campus)

Description

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.

There will also be an opportunity for stakeholders to provide comments during an Open Public Comment Session at the workshop. Sign-up for Open Public Comment will take place on the day of the meeting.

Those who register for the webcast will be emailed a link to the webcast a few days before the event. The webcast will allow you to view the workshop live, submit comments throughout the duration of the workshop, and respond to any discussion/polling questions.

For more information, including workshop materials, please refer to the FDA meeting website here: http://www.fda.gov/Drugs/NewsEvents/ucm501389.htm.