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U.S. Department of Health and Human Services

Advisory Committees

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October 21-22, 2010: Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement

CenterDateTimeLocation
CDEROctober 21, 2010
October 22, 2010
8:30 a.m. to 4:30 p.m.
8:30 a.m. to 4:00 p.m.
Hilton Washington DC/North Gaithersburg
620 Perry Parkway
Gaithersburg, Maryland

Agenda

The committee will discuss considerations for the design of postmarketing studies for new drug application (NDA) 22-272 , OxyContin (oxycodone hydrochloride controlled-release) Tablets, Purdue Pharma, Inc. and NDA 22-321 Embeda (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules, Alpharma Pharmaceuticals, LLC and King Pharmaceuticals Research & Development, Inc., approved for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The postmarketing studies are intended to be epidemiological or observational studies that will assess the known serious risks of these products and whether product-specific properties which are intended to deter misuse and abuse actually result in a decrease in the risks of misuse and abuse, and their consequences: addiction, overdose, and death.

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 October 14, 2010.
  • Oral presentations from the public will be scheduled between approximately approximately 10:45 a.m. and 11:45 a.m. on October 22, 2010. Those desiring to make 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 October 6, 2010.

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 October 7, 2010.

Contact Information

  • Kalyani Bhatt, B.S., M.S.
    Center for Drug Evaluation and Research
    Food and Drug Administration
    10903 New Hampshire Avenue
    WO31-2438
    Silver Spring, MD 20993-0002
    Phone: 301-796-9001
    Fax: 301-847-8533
    E-mail: kalyani.bhatt@fda.hhs.gov
  • FDA Advisory Committee Information Line
    1-800-741-8138
    (301-443-0572 in the Washington DC area)
    Code: 3014512529 or 3014512535
    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 appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

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.

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 Kalyani Bhatt at (301) 796-9001 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 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).