The companion diagnostics (CDx) market has become a cornerstone in the advancement of personalized medicine, offering critical support for targeted therapies and improving treatment outcomes. As Regulatory bodies heighten their focus on the safety, effectiveness, and clinical integration of CDx, performance evaluation has emerged as a vital requirement for manufacturers across the globe.
This whitepaper provides an in-depth exploration of the Regulatory frameworks governing the performance evaluation of companion diagnostics in both the United States and the European Union. It discusses key components such as scientific validity, analytical and clinical performance, lifecycle management requirements like Post-Market Performance Follow-up (PMPF), and the critical role of Regulatory coordination with the FDA, EMA, and Notified Bodies.
By understanding these evolving expectations, manufacturers can streamline their Regulatory submissions, ensure clinical reliability, and contribute effectively to the expanding landscape of precision healthcare.
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