The recently passed Food and Drug Administration Amendments Act (FDAAA) has the potential to transform postmarketing surveillance in the United States. However, the FDAAA is only one piece of the rapidly changing global drug safety landscape. The changes taking place in the Europe Union are every bit as profound-and every bit as complicated. Each month, Rx Risk Management Report offers detailed analysis about these changes and timely advice from FDA officials and senior industry executives on the most effective risk management strategies. It also includes the most detailed case studies available of existing risk management programs and expert legal advice on reducing liability.


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  • The FDA's Janet Woodcock assesses the challenges and opportunities presented by the FDA Amendments Act (FDAAA)
  • Former FDA and CMS Chief Mark McClellan outlines the key ingredients for an improved post-marketing environment
  • A senior FDA official offers the agency's perspective on risk minimization action plans
  • Industry leader John Ferguson offers an incisive perspective on the changing role of benefit in global risk management
  • Experts assess the Vioxx settlement: Why did Merck settle? And why was the settlement for so much less than originally anticipated? Will the settlement stand up under legal challenge, and what will remain of the Vioxx litigation if it does?
  • Case studies:
    • Tysabri: Balancing risk and benefit
    • Accutane: iPledge implements Advisory Committee recommendations amidst complaints
    • Thalidomide: Risk management approaches for RevAssist and S.T.E.P.S
  • Also:
    • Pharmacovigilance in the European Union: The latest on Volume 9A
    • Leveraging drug registry tools to assess safety and performance
    • Signal Detection: Best methods for case assessment and data mining in pharmacovigilance

  • Axel Olsen, Ph.D., President, Pharmaceutical Safety Institute, Philadelphia, PA, Former Vice President of Global Medical Operations, Wyeth Pharmaceuticals
  • Edward Berg, J.D., Senior Counsel, R&D Development, Bristol-Myers Squibb, New York, NY
  • Daniel Kracov, J.D., Chair, Pharmaceutical and Medical Device Practice, Arnold & Porter, Washington, DC
  • John Ferguson, M.D., Vice President & Global Head Pharmacovigilance & Medical Safety, Novartis Vaccines & Diagnostics, Cambridge, MA
  • Maurits Lugard, J.D., Maurits J.F. Lugard, Partner, Sidley Austin, Brussels, Belgium, Former Member, European Commission's Legal Service
  • Louis Morris, Ph.D., President, Louis A. Morris & Associates, Inc., Dix Hills, NY, Member, FDA Drug Safety and Risk Management Advisory Committee, former Director, FDA's Division of Drug Marketing, Advertising, and Communications
  • Wayne Pines, President, Regulatory Services and Health Care, APCO Associates, Washington, DC, Former FDA Chief of Consumer Education and Information and Associate Commissioner for Public Affairs
  • Annette Stemhagen, Ph.D., Vice President, United BioSource Corporation, Epidemiology and Risk Management, Bethesda, MD, Industry Representative, FDA Drug Safety and Risk Management Advisory Committee


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