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These Are The Top Priorities & Challenges For New CDER Director Patrizia Cavazzoni, M.D. By Lowell M. Zeta and Lynn Mehler, Hogan Lovells Scientific breakthroughs have revolutionized the development of new and more personalized therapies to address unmet medical needs through enhanced technologies and data-informed capabilities. Advances in data infrastructure, clinical trial design, and other medical product technologies and the 21st Century Cures Act and other legislation aim to bring new innovations to patients who need them faster. These developments are requiring the FDA to rethink the ways it applies and interprets the law and to speed up its efforts to adopt innovative scientific approaches to inform regulatory decisions that make products more effective, safer, and available sooner.

United statesJanet woodcockHogan lovellsPatrizia cavazzoniJacqueline corrigan curayLynn mehlerOffice of medicalRegulatory science while retaining publicOncology centerDrug centerOffice of new drugsLife sciencesHogan lovell life sciences health careCentury cures actDrug evaluationActing commissioner