Regulatory Rapporteur September 2010

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Front Cover
Volume 7 Issue 9

In This Issue

  • FDA’s electronic submissions gateway
  • Primary IND applications
  • Due diligence
  • Canada update

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Regulatory Rapporteur September 2010MembersFull Issue3MBPDF
Getting started with the FDA’s electronic submissions gatewayPublic525KBPDF
A closer look at the MHRA - An interview with Prof Kent Woods, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA)Members508KBPDF
Canada – News updateMembers505KBPDF
Delving into product development due diligenceMembers493KBPDF
International conference on VICH: Impact and future expectationsMembers625KBPDF
Managing primary IND applications with the FDAMembers627KBPDF
Regulatory and scientific considerations for the follow-up of patients treated with gene therapy medicinal products: an EU perspectiveMembers638KBPDF
Regulatory updates - Across the pond and around the globeMembers486KBPDF
The current status of biosimilar biologics – Part 1: An international perspectiveMembers515KBPDF
The Medical Devices ExchangeMembers464KBPDF