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Food and Drug Administration

Risk Communication Advisory Committee

February 28 - 29, 2008

FDA

Topic I:  Background on FDA Risk Communication, February 28, 2008

Overview of Risk Communication at FDA, Nancy M. Ostrove, Ph.D., Senior Advisor for Risk Communication, FDA (2008-4347s1-01(ppt) (pdf)

Legal Authorities and Protections Relevant to Risk Communication:  Speech FDA regulates William A. McConagha, Assistant Commissioner for Accountability and Integrity, FDA (2008-4347s1-02) (ppt) (pdf)

Legal Authorities and Protections Relevant to Risk Communication:  Speech FDA generates, William A. McConagha, Assistant Commissioner for Accountability and Integrity, FDA (2008-4347s1-03) (ppt) (pdf)

New in FDA Amendments Act, Jarilyn Dupont, Director of Regulatory Policy, Office of Policy, FDA (2008-4347s1-04) (ppt) (pdf)

FDA research:  Clearance requirements and implications, Steven L. Bradbard, Ph.D., Team Leader for Consumer Studies, Center for Food Safety and Applied Nutrition, FDA (2008-4347s1-05) (ppt) (pdf)

Existing Risk Communications Programs – Overview, Panel, FDA (2008-4347s1-06) (ppt) (pdf)

Topic II:  FDA Draft Press Release Template on Product Recalls, February 29, 2008

Communication about Product Recalls, CAPT David Elder, Director, Office of Enforcement, FDA Office of Regulatory Affairs (2008-4347s2-01) (ppt) (pdf)

Literature Review: What do we know about the public’s awareness, understanding, and
perceptions of recalls concerning FDA-regulated products?, Amy Lando, M.P.P. Consumer Science Specialist, Center for Food Safety and Applied Nutrition, FDA (2008-4347s2-02) (ppt) (pdf)

Comments from FDA Consultant:  Michael Wogalter, Ph.D., Professor of Psychology, North Carolina State University (2008-4347s2-03) (ppt) (pdf)

Open Public Hearing (Updated 7/22/08)

AdvaMed: Statement to the FDA Risk Communication Advisory Committee (pdf)

Heart Rhythm Society: Statement to the Food and Drug Administration Risk Communication Advisory Committee (pdf)

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