Advisory Committee Meeting | In Person

Event Title

April 25, 2016: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee

April 24, 2016

Date:: April 24, 2016
Time:: 8:00 PM - 8:00 PM ET

What is an advisory committee?

Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. Please see, "Advisory Committees Give FDA Critical Advice and the Public a Voice," for more information.

UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: April 25, 2016: Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement

Updated Information (as of 4/19/2016):

The meeting time and Public Participation Information portions have been changed for the April 25, 2016 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. All other information remains the same.

The meeting time has been extended to 8:00 a.m. to 6:30 p.m.

Center	Date	Time	Location
CDER	April 25, 2016	8:00 a.m. to 6:30 p.m.	College Park Marriott Hotel and Conference Center Chesapeake Ballroom 3501 University Blvd. East Hyattsville, MD 20783

The Public Participation Information portion is changed to extend the time for oral presentations and reads as follows:

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Written submissions may be made to the contact person on or before April 11, 2016.
Oral presentations from the public will be scheduled between approximately 2:00 p.m. and 4:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person 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.

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.

ORIGINAL INFORMATION

Center	Date	Time	Location
CDER	April 25, 2016	8:00 a.m. to 5:30 p.m.	College Park Marriott Hotel and Conference Center Chesapeake Ballroom 3501 University Blvd. East Hyattsville, MD 20783

Agenda

The committee will discuss new drug application (NDA) 206488, eteplirsen injection for intravenous infusion, sponsored by Sarepta Therapeutics, Inc., for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.

Meeting 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: 2016 Meeting Materials, Peripheral and Central Nervous System Drugs Advisory Committee

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Written submissions may be made to the contact person on or before April 11, 2016.
Oral presentations from the public will be scheduled between approximately12:40 p.m. and 2:40 p.m. Those individuals interested in making formal oral presentations should notify the contact person 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.

Webcast Information

CDER plans to provide a free of charge, live webcast of the April 25, 2016 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. While CDER is making a webcast available to the public for this meeting, there may be instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm

CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.

Contact Information

Moon Hee V. Choi, PharmD

Center for Drug Evaluation and Research

Food and Drug Administration

10903 New Hampshire Avenue

WO31-2417

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)

Please call the Information Line for up-to-date information on this meeting.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Website and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Moon Hee V. Choi at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s website or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).