FDA proposes process modernisation to support new drug development

FDA

4 June 2018 - The staff of the FDA’s Center for Drug Evaluation and Research (CDER) always tries to utilise cutting-edge science and up-to-date process management, befitting our stature as the global “gold standard” in drug regulation. 

Maintaining that standard requires us to keep up with evolving technology and the latest scientific, medical and regulatory advances. Current factors impacting drug development include the genomic revolution, the rise of targeted therapy, the availability of digital health data, the focus on patient involvement, complex drug-device combinations, globalisation of drug development and harmonisation of international standards. 

To be successful drug regulators, we reach well beyond the borders of the FDA.

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Michael Wonder

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Michael Wonder