The Center for Drug Evaluation and Research (CDER) has established a new Quantitative Medicine Center of Excellence (QM CoE) aimed at advancing the integration of quantitative methodologies in drug development and regulatory decision-making. This initiative is designed to ensure a consistent and evolving application of quantitative medicine principles across CDER’s operations.
The QM CoE will serve as a pivotal resource for regulatory professionals, offering guidance and support in the application of quantitative approaches that can enhance the efficiency and effectiveness of drug evaluation processes. By fostering collaboration among various stakeholders, the center aims to streamline the integration of quantitative data into regulatory frameworks, ultimately improving the quality of submissions and outcomes.
This development signifies a strategic shift towards more data-driven decision-making in the pharmaceutical industry, which may lead to faster approvals and improved patient outcomes. As the industry adapts to these changes, professionals in regulatory, QA/QC, CMC, and sourcing roles will need to align their practices with the evolving standards set forth by the QM CoE.
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