Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary by Institute of Medicine of the National Academies

Author:Institute of Medicine of the National Academies
Language: eng
Format: epub
Tags: Health and Medicine : Medical Technologies and Treatments. Health and Medicine : Policy, Reviews and Evaluations. Health and Medicine
Publisher: NATIONAL ACADEMIES PRESS
Published: 2011-02-15T00:00:00+00:00

Nordenberg also stressed that clear outcome measures will be necessary for evaluating, assessing, and ultimately documenting the impact of this collaborative model. A COE model for FDA’s regulatory science framework, said Nordenberg, could be used for clinical trials, safety surveillance, and comparative effectiveness research. “The structure and operational model for the COE is an important enabler of innovation, outcomes, and ultimately public health impact,” concluded Nordenberg.

Moving Toward a COE Structure

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