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U.S. Department of Health and Human Services

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Drug Safety Oversight Board Meeting: June 19, 2008, Public Summary

  • The Executive Director updated the Board on Public Health Advisories (PHAs), Information for Healthcare Professionals (HCP) Sheets, Early Communications about an Ongoing Safety Review (EC) and Communications About an Ongoing Safety Review posted since the April 17, 2008 meeting (all available at: Index to Drug-Specific Information), and those in development.

  • The Director of Regulatory Policy, Jarilyn Dupont, representing FDA’s Office of Policy, presented background information to the Board on the draft “Guidance for Industry” concerning the Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of  Approved Drugs and Approved or Cleared Medical Devices, published for comment in February 2008.

  • The Board discussed the data about the potential for malignancies with the use of TNF blockers as described in a recent Early Communication About an Ongoing Safety Review (TNF Blockers).