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Joint Meeting of the Antiviral Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee
| Center |
Date |
Time |
Location |
| CDER |
October 29, 2008
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8:00 am - 5:00 pm
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Hilton The Ballrooms
1750 Rockville Pike
Rockville, MD |
Agenda
The committee will provide advice on types of studies and trial designs needed for an influenza antiviral MedKit for the treatment or prophylaxis of pandemic influenza and discuss publicly the proposed development program that would support an application for such a MedKit. Issues such as the role of personal MedKits, home stockpiling, non-prescription availability of influenza medications, and interfaces of home readiness with public health systems, will be raised in the course of the discussions.
Meeting Materials
Links to meeting materials will be added as they become available.
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 15, 2008.
- Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m., October 29. 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, 2008.
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, 2008.
Contact Information
- Paul Tran
Center for Drug Evaluation and Research (HFD-21)
Food and Drug Administration
5600 Fishers Lane (for express delivery, Fishers Lane, rm. 1093)
Rockville, MD 20857
301-827-7001
FAX: 301-827-6776
Email: paul.tran@fda.hhs.gov, or
FDA Advisory Committee Information Line, 1-800-741-8138(301-443-0572) in the Washington, DC area), code 3014512531 and 301-4512541
Please call the Information Line for up-to-date information on this meeting.
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Date created: September 16, 2008 |
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