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U.S. Department of Health and Human Services

Advisory Committees

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UPDATED PUBLIC PARTICIPATION INFORMATION: December 12-13, 2012: Meeting of the Drug Safety and Risk Management Advisory Committee Meeting Announcement

UPDATED PUBLIC PARTICIPATION INFORMATION: December 12-13, 2012 Drug Safety and Risk Management Advisory Committee Meeting

Updated Information (as of 12/7/2012):

UPDATED INFORMATION
The Procedure portion has been updated to an open public hearing from approximately 1:15 p.m. to 1:45 p.m. on December 12 and an open public hearing from approximately 11 a.m. to 11:30 a.m. on December 13.

Public Participation Information
The sentence “Oral presentations from the public will be scheduled between approximately 1:40 p.m. to 2:10 p.m. on December 12, and 12:45 p.m. to 1:15 p.m. on December 13” should be updated to read “Oral presentations from the public will be scheduled between approximately 1:15 p.m. to 1:45 p.m. on December 12, and 11 a.m. to 11:30 a.m. on December 13”.

 

Original Information:

CenterDateTimeLocation
CDERDecember 12, 2012
December 13, 2012
8:00 a.m. to 5:30 p.m.
8:00 a.m. to 3:30 p.m.
FDA White Oak Campus
Building 31
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland

Agenda

The Food and Drug Administration Amendments Act of 2007 requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with Elements to Assure Safe Use (ETASU) before CDER's Drug Safety and Risk Management Advisory Committee (DSaRM). The Agency plans to present information on the risk management of teratogens, some of which have REMS with ETASU.

On December 12, 2012, the DSaRM advisory committee will meet to discuss the various strategies used by the Agency to define and address teratogenic risk, including requiring REMS with ETASU. The discussion will include an evaluation of the different strategies and the decision framework for selecting risk management strategies for teratogens. The committee will discuss whether the risk management strategies, including REMS with ETASU, assure safe use, are not unduly burdensome to patient access to the drug, and to the extent practicable, minimize the burden to the health care delivery system.

On December 13, 2012 the committee will discuss two common risk management tools used to minimize the risk of teratogens – contraception and pregnancy testing. The committee will discuss considerations for standardizing recommendations for use of these two tools.

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

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 November 28, 2012.
  • Oral presentations from the public will be scheduled between approximately 1:40 p.m. to 2:10 p.m. on December 12, and 12:45 p.m. to 1:15 p.m. on December 13. 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 November 19, 2012.

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 November 20, 2012.

Webcast Information

CDER plans to provide a free of charge, live webcast of the December 12 and 13, 2012, meeting of the Drug Safety and Risk Management Advisory Committee. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are 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: 2012 Meeting Materials, Drug Safety and Risk Management Advisory Committee.

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

  • Kristina Toliver
    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
    E-mail: DSaRM@fda.hhs.gov
  • FDA Advisory Committee Information Line
    1-800-741-8138
    (301-443-0572 in the Washington DC area)- follow the prompts to the desired center or product 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 Web site 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 physical disabilities or special needs. If you require special accommodations due to a disability, please contact Kristina Toliver at (301) 796-9001 at least 7 days in advance of the meeting.

Information regarding ground transportation, airport information, lodging, driving directions and visitor parking, and security can be accessed at: Public Meetings at the FDA White Oak Campus.

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).