Insights into post-marketing clinical validation of companion diagnostics with reference to the FDA, EMA, PMDA, and MFDS.

ABSTRACT: Companion diagnostics are increasing clinical demand globally, regulatory frameworks for clinical validation are strengthening. Post-marketing verification is an important aspect of providing high-quality, personalized treatment to patients because it can ensure long-term safety and effectiveness, while also generating effective risk management and performance evidence. Certain compliance issues related to the requirements for post-marketing clinical trials can potentially impact manufacturers, so it is essential to have a clear understanding of the regulatory process. In this study, we perform an institutional comparison as well as a case analysis by country (U.S. Food & Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency, and Ministry of Food and Dr

SUBMITTER: Kang SL 

PROVIDER: S-EPMC11490922 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature