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FDA Releases New Date for Eteplirsen Ad Comm

At long last we have received information regarding the rescheduled Advisory Committee for Sarepta (eteplirsen). The Ad Comm will take place on Monday, April 25 at the College Park Marriott Hotel & Conference Center (a non-FDA campus venue) due to the overwhelming response from our community with the previously scheduled eteplirsen Ad Comm and the historic turn-out anticipated.

We are excited that people with Duchenne and their families will have the opportunity to share their experiences with regulators and we remain hopeful that the FDA will render the decision we all so desperately want: APPROVAL.

See below for updated information on submitting your written testimony, oral testimony, and other Ad Comm details. Unfortunately, if you submitted written testimony last time or if you were scheduled for the open public hearing, you must resubmit for both. As always, PPMD will keep you up-to-date on details about the Ad Comm as they become available.

Details

View the Federal Register Notice


  • 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 
  • 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.)


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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