Companion Diagnostics: Development, Regulation and Compliance Considerations

companion diagnostics

Understanding Companion Diagnostics Development

The need for personalized medicine has successfully brought together and fully integrated the previously separate activities of drug and in vitro diagnostic (IVD) device development. This white paper outlines the necessary considerations for companion diagnostic test (CDx) development inclusive of the impacts of regulatory and quality compliance expectations in the U.S. and European jurisdictions.

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