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Diane Publishing Books
Medical Product Oversight: FDA Needs More Strategic Planning to Guide Its Scientific Initiatives
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Marcia Crosse (au)
The Food and Drug Administration (FDA) has faced challenges regulating medical products, owing in part to rapid changes in science and technology. In 2010, FDA established a regulatory science initiative that identified eight priority areas for medical products where new research was needed to advance its mission. In 2012 FDA was required to establish a plan for measuring its progress on its regulatory science efforts. This report (1) evaluates FDAäó»s strategic plannning efforts to address its regulatory science priorities; (2) describes FDAäó»s funding targeted at regulatory science projects; and (3) describes the achievements of selected FDA regulatory science projects. Includes recommendations. Table and figures. This is a print on demand report.
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