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T05-29 |
Media Inquiries: |
As part of its ongoing effort to continue to improve how it communicates information about risks and benefits of drugs, the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) will convene a Public Hearing on December 7 and 8, 2005 at the National Transportation Safety Board Boardroom and Conference Center 429, L'Enfant Plaza, Washington, D.C. to discuss CDER's current risk communications and outreach strategies.
FDA believes it is critical that risk communication be timely, accurate, and easily accessible, and it must recognize health literacy limitations and include the needs of a multicultural population.
The purpose of the public hearing is to obtain public input on CDER's risk communication tools, identify stakeholders for collaboration and implementation of additional tools and obtain understanding of the strengths and weaknesses of CDER's existing risk communication.
The Part 15 public hearing will address six questions related to documents currently distributed by FDA . The questions being posed by FDA will help the agency learn which tools are effective and how these risk communications can be improved. These tools include Patient Information Sheets, Healthcare Professional Information Sheets, Public Health Advisories, Press Releases, the MedWatch Listserv Safety Updates, Patient Safety News, CDER Educational Campaigns, and the CDER Internet site. (The websites for these documents are available in the Federal Register (FR) notice.)
Examples of questions that CDER intends to ask include:
Those planning to participate in providing oral comments must register by November 7, 2005.
For additional information on registration, please visit CDER's webpage: http://www.fda.gov/cder/meeting/RiskComm2005/default.htm.
Federal Register Notice of Public Meeting:
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-19759.htm
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-19759.pdf
Submit written or electronic notices of participation and comments to:
Division of Dockets Management (HFA-305)
Food and Drug Administration,
5630 Fishers Lane, Room 1061
Rockville, Maryland 20852
E-mail: FDADockets@oc.fda.gov
Electronic Comments
Date and Time:
December 7 and 8, 2005 from 8:00 a.m to 4:30 p.m.
Place:
National Transportation Safety Board: Board Room and Conference Center
429 L'Enfant Plaza
Washington, D.C.
Register by November 7, 2005
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