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The Complete Guide to Companion Diagnostics: Market Environment Products and Companies
Date:12/12/2012

e that some standardisation of the guidelines is necessary.



An example of the regulatory muddle can be seen in drug labels. From an analysis of labels of previously-approved products it is possible to identify drugs that require companion diagnostics, although the lack of clear regulatory guidance means that there is considerable variation in how this information is presented in the drug label.


This is a developing area. The FDA is currently in Phase III of its programme to provide guidance for personalised medicine. Final guidance for in vitro companion diagnostic devices was anticipated for the end of June 2012. However, at the time of publication of this report, this had not materialised.



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Diagnostics Industry: The Complete Guide to Companion Diagnostics: Market Environment Products and Companies



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