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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease
related to efficacy, safety, and use during the lifecycle of drugs and other medical products, and it would support the centers in their mission to “help the public get the accurate, science-based information they need to use medicines and foods to improve their health.”
The committee recommends that the new Office of Drug Safety Policy and Communication should develop a cohesive risk communication plan that includes, at a minimum, a review of all center risk communication activities, evaluation and revision of communication tools for clarity and consistency, and priority setting to ensure efficient use of resources.
To support improvements in drug safety and efficacy activities over a product’s lifecycle, the committee recommends that the Administration should request and Congress should approve substantially increased resources in both funds and personnel for the Food and Drug Administration.
SOURCE: IOM (2007b).
IOM (Institute of Medicine). 2007a. Cancer biomarkers: The promises and challenges of improvingdetection and treatment. Washington, DC: The National Academies Press.
IOM. 2007b. The future of drug safety: Promoting and protecting the health of the public. Washington, DC: The National Academies Press.