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FDA's Communication of Drug
Safety Information
December 7 and 8, 2005 Public Hearing
October 3, 2005
The Food and Drug Administration (FDA) is holding a public
hearing entitled “ FDA’s Communication of Drug Safety Information”
on December 7 and 8, 2005, at the National Transportation Safety
Board Boardroom and Conference Center, 429 L’Enfant Plaza,
Washington, D.C. We hope you will save these dates on your calendar,
and that you will not only attend the meeting, but also sign up to
speak and provide comments on this important public health issue.
The purpose of the meeting is to obtain public input on the
strengths and weaknesses of current risk communication tools
employed by Center for Drug Evaluation and Research (CDER) and to
identify stakeholders for collaboration and implementation of
additional tools. This hearing is part of the Agency’s ongoing
efforts to solicit comments on CDER’s risk communication tools, such
as Patient and Healthcare Professional Information Sheets, Talk
Papers, Public Health Advisories, Press Releases, MedWatch Listserv
notices, Patient Safety News, CDER educational campaigns, and the
CDER Internet site. Your comments will help us learn which tools are
effective and how these risk communication efforts can be improved.
Details about the meeting, including the questions where FDA is
requesting specific feedback, were published in the Federal Register
on October 3, 2005. Other information about the meeting is available
at:
http://www.fda.gov/cder/meeting/RiskComm2005/default.htm.
If you are unable to attend in person, the docket will be accepting
written comments to the questions until January 9, 2006. If
attending the meeting, we recommend that you take the Metro because
parking is limited. The Conference Center is located at the L’Enfant
Plaza Station on Metro’s Green, Yellow, Blue and Orange Lines.
We look forward to seeing you at the Public Hearing on “FDA’s
Communication of Drug Safety Information” on December 7 and 8 and
invite you to share this announcement with interested colleagues. To
reach as many interested people as possible, we have disseminated
this announcement very broadly. We apologize if you have received a
duplicate announcement of this meeting.
Sincerely,
/s/
Steven Galson, M.D., MPH
Director
Center for Drug Evaluation and Research
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Date created: October 3, 2005 |
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