The Duchenne community is working closely together to prepare for the April 25 Advisory Committee Meeting for Sarepta’s therapy eteplirsen. PPMD, the Duchenne Alliance, the Center for DMD at UCLA, Jett Foundation, and the Race to Yes have put together a short video so that you can learn about the different ways you can become involved in this historic event. Whether submitting written testimony, attending the Ad Comm in person, participating in the Open Public Hearing, or doing all three, this community is strongest when we work together and collaborate. After watching this video, if you have any questions, do not hesitate to reach out to MakeDuchenneHistory@gmail.com or visit MakeDuchenneHistory.com for more information on how you can get involved.
Together, we will end Duchenne.
This meeting is a reschedule of a postponed meeting announced in the Federal Register of
December 18, 2015 (80 FR 79047), originally scheduled for January 22, 2016.
College Park Marriott Hotel and Conference Center, Chesapeake Ballroom, 3501 University Blvd. East, Hyattsville, MD 20783. The conference center's telephone number is 301-985-7300.
Moon Hee V. Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993-0002
FDA Advisory Committee Information Line: 1-800-741-8138 (301-443-0572 in the Washington, DC area).
Oral presentations from the public will be scheduled between approximately 12:40 p.m. and 2:40 p.m. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 4, 2016.
Written submissions may be made to the contact person (Moon Hee V. Choi) on or before April 11, 2016.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available athttp://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.
For more information about the FDA Ad Comms, please visit the links and resources that we at PPMD have compiled over the past few months with the assistance of our community members, regulatory advisors, and federal agency partners: