FDAAA Meeting Archive

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New Federal Legislation for Clinical Trial Registration and Results Disclosure: Implications for Publication Planning Professionals and Biomedical Publications
Thursday, January 17, 2008

Food and Drug Amendments Act of 2007:Implications for Public Planning Professionals and for Bio-Medical Publication
Larry Hirsch, MD/ISMPP

FDAAA Title VIII: How Did We Get Here (and where exactly is here)?
Amy Muhlberg, PhD/SENATE COMMITTEE ON HEALTH, EDUCATION, LABOR AND PENSIONS

FDA Amendments Act of 2007 Title VIII – Clinical Trial Databases: A View from FDA
Terry Toigo/FDA OFFICE OF SPECIAL HEALTH ISSUES 

What Does FDAAA – Especially Title VIII – Mean For Industry and Publication Planning Professional?
Scott M. Lassman, Esq/WILMERHALE 

Impact of the 2007 FDA Amendments Act (FDAAA) on Data Disclosure at GSK
Frank W. Rockhold, PhD/GSK RESEARCH & DEVELOPMENT

Title VIII-Clinical Trial Databases: A Perspective from an Academic Trialist
Kenneth A. Jamerson, MD/UNIVERSITY OF MICHIGAN HEALTH SYSTEM

Whither the Ingelfinger Rule; An Editor’s Perspective
Trish Groves, MBBS, MRCPsych/BRITISH MEDICAL JOURNAL 

The Food and Drug Administration Amendments Act of 2007 and Their Impact on Transparency of Pharmaceutical Research
Alan Goldhammer, PhD/PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA)