CDER Quantitative Medicine Center of Excellence

Date

September 25, 2024

Category

US Regulations

Description

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

NOTE: The Windsor Framework only applies to human medicines. However, in December 2022 the European Commission announced that the transitional arrangements for veterinary products, which have been in place since the UK left the EU, had been extended to December 2025.