The FDA has officially launched the Quantitative Medicine Center of Excellence (QM CoE), aimed at advancing the application of quantitative methods in drug development and regulatory science. This initiative is governed by leadership from multiple FDA offices, including the Office of Generic Drugs, Office of New Drugs, Office of Pharmaceutical Quality, and Office of Translational Sciences. The establishment of the QM CoE signifies a strategic move towards integrating quantitative approaches into the regulatory framework, enhancing the precision and efficiency of drug evaluation.
As the pharmaceutical landscape becomes increasingly complex, the need for robust quantitative methodologies is paramount. The QM CoE is expected to foster collaboration across various sectors, driving innovation in drug development processes. This initiative not only underscores the FDA’s commitment to modernizing regulatory practices but also highlights the growing importance of data-driven decision-making in ensuring drug safety and efficacy.
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