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Scientific Advice and Guidance Available

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In April, we reported how a joint pilot scheme operated by the UK Medicines & Healthcare Products Regulatory Agency (MHRA), the UK Health Technology Assessment (HTA) body and the National Institute for Health & Clinical Excellence (NICE), was being run for companies to seek parallel scientific advice.  Recently, the European Medicines Agency has described how it is also exploring ways to engage with HTA bodies, with the aim that both regulatory and pharmacoeconomic considerations may be taken into account in the provision of scientific advice.  The first meeting investigating how the Agency's scientific advice could co-operate with that of national HTA bodies was held on 25 October 2010.

Such co-operation represents an attractive offering to companies developing new medicines, especially those with higher technology products that encounter interesting scientific challenges for development as well as greater cost : benefit scrutiny. 

If you are in need of scientific advice and wish to maximise your chances of favourable guidance, Wainwright Associates can help. Please email or telephone +44 1628 530554.

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