Regulatory Rapporteur July/August 2016

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Front Cover
Volume 13 Issue 7

In This Issue

  • FOCUS - Over-the-counter medicines
  • PLUS
  • Considerations for veterinary vaccine development
  • Orphan drug designation – a blueprint for success

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Regulatory Rapporteur July/August 2016MembersFull Issue2MBPDF
Editorial: Over-the-counter medicines – welcome to big business!Public36KBPDF
Regulatory priorities to develop and support self-carePublic71KBPDF
Investigating biosimilar development and registration: A  filgrastim case study – Part 2Members87KBPDF
Key regulatory considerations for veterinary vaccine development in the EU and the USMembers75KBPDF
Obtaining orphan status – A key milestone within a development strategyMembers168KBPDF
Options To Consider when registering human medicines in the EUMembers70KBPDF
Over-the-counter products in the US regulatory environmentMembers69KBPDF