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  • Feature ArticlesFeature Articles

    Challenges to contemporaneous FDA approval for companion diagnostics and their drug partners

    Abstract Ideally, the drug development pathway aligns with the companion diagnostics (CDx) validation on stages and steps in that the efficacy of the drug and CDx are clinically validated together as part of a phase 3 trial. However, the market is trending toward earlier submissions from the drug side. Specifically, if efficacy is shown in a phase 2 study, then a new drug application (NDA) or biologics license application (BLA) could be submitted using this information,...