Regulatory Rapporteur April 2009

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Front Cover
Volume 6 Issue 4

In This Issue

  • Drug safety, medication safety, patient safety
  • FDA draft guidance on genotoxic and carcinogenic impurities
  • Adverse event reporting to institutional review boards
  • Insight on the CDER’s review process for QT studies

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Regulatory Rapporteur April 2009MembersFull Issue2MBPDF
Drug safety, medication safety, patient safety: An overview of recent FDA guidances and initiativesPublic70KBPDF
A review of the new draft FDA guidance on genotoxic and carcinogenic impuritiesMembers58KBPDF
Editorial - US FDA in 2009Members44KBPDF
EU Regulatory Intelligence: Updates January – February 2009Members41KBPDF
Insight on the interdisciplinary review team for QT studies in the FDAMembers50KBPDF
Maple Leaf News - Update from CanadaMembers48KBPDF
NEWS insight - Hype and hope for world’s fi rst embryonic stem cell studyMembers48KBPDF
Overview of FDA guidance for clinical investigators, sponsors and IRBs: adverse event reporting to IRBsMembers89KBPDF
Regional update – A message from the TOPRA North America Leadership TeamMembers79KBPDF
The Exchange - Coordinated by Cambridge Regulatory Services Limited (CambReg) Members80KBPDF