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How You Can Participate in Upcoming FDA Advisory Committee Meetings

UPCOMING AD COMMS

Sarepta

View the Federal Register Notice

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.

 

  • Date & Time
    • April 25, 2016, from 8 a.m. to 5:30 p.m. 

      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.

  • Name of Committee
    • Peripheral and Central Nervous System Drugs Advisory Committee
  • Location
    • 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.

  • Contact Person
    • 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

    • Phone: 301-796-9001

    • FAX: 301-847-8533

    • Email: PCNS@fda.hhs.gov

    • FDA Advisory Committee Information Line: 1-800-741-8138 (301-443-0572 in the Washington, DC area).

  • How to Request to Speak at Ad Comm
    The Duchenne community is working closely together to organize our public testimony in order to avoid requiring the FDA to implement a 'lottery system' for the open public hearing. 
    For those interested in collaborating to ensure messages are not duplicated and are most impactful please considering contacting us to speak about the Open public hearing. ryan@parentprojectmd.org.

    • Those individuals interested in making formal oral presentations should notify the contact person (Moon Hee V. Choi) and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 1, 2016.
    • 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.

  • How to Submit Written Testimony 
    • Written submissions may be made to the contact person (Moon Hee V. Choi) on or before April 11, 2016.

    • Everyone has a chance to participate in Ad Comm via a written testimony. That includes those chosen to speak during the OPH. Click here for more details and guidance on writing testimonies.
    • Please also consider emailing your written submission to makeduchennehistory@gmail.com - we are compiling all submissions into a printed piece to submit to the FDA. 
  • How to Access Background Materials
    • 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 at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

  • Let Us Know If You Are Attending
    • If you are attending in person please let us know here: http://Make-Duchenne-History.eventbrite.com
      (YOU DO NOT NEED TO BRING A TICKET WITH YOU. This is just so we have a head count and can keep in touch! We will not use your contact information for any other purpose.)

PAST AD COMMS


BioMarin

FDA Issues Complete Response Letter for Kyndrisa (drisapersen)

Download the Federal Register notice

LEARN MORE

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:

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