CDER issues New Drugs Regulatory Program Modernization – Impact Narrative Update 2023

https://www.fda.gov/media/179517/download?attachment=&utm_medium=email&utm_source=govdelivery The New Drugs Regulatory Program (NDRP) helps CDER achieve its mission to ensure human drugs are safe and effective and available to the American public. In 2017, CDER began an initiative to modernize NDRP, to continuously improve regulatory science and review. As part of this modernization initiative, CDER identified six strategic objectives and then, guided by these objectives, formed interdisciplinary workstreams to identify areas for improvement, develop recommendations, design changes, and drive implementation. The report provides a detailed look at the strategic objectives and impact of NDRP modernization progress, as well as on continued efforts toward reaching program goals. This report illustrates how the progress thus far furthers NDRP’s ability to achieve its mission by staying ahead of the rapid growth and evolutions of drug development, review, and surveillance activity; the increasing complexity of innovative therapies under development; and the expanding public engagement between FDA and stakeholders.