CDER Quantitative Medicine Center of Excellence

US FDA has recently launched the new CDER Quantitative Medicine (QM) Center of Excellence (CoE). ?The goal of this CoE is to facilitate and coordinate the continuous evolution and consistent application of QM across CDER. QM involves the development and application of exposure-based, biological, and quantitative modeling and simulation approaches derived from nonclinical, clinical, and real-world sources to inform drug development, regulatory decision-making, and patient care.

Further details can be found in a conversation with Rajanikanth Madabushi, lead for the QM CoE and associate director for Guidance and Scientific Policy in the Office of Clinical Pharmacology in the Office of Translational Science Super Office, at https://www.fda.gov/drugs/cder-conversations/streamlining-drug-development-and-improving-patient-care-cder-quantitative-medicine-center?utm_medium=email&utm_source=govdelivery