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Identifying CDER’s Science and Research Needs Report
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2011-07-25
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Center for Drug Evaluation and Research
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키워드
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Identifying_CDER’s_Science_and_Research_Needs_Report.PDF
Identifying CDER’s Science and Research Needs Report
Background
Purpose
This document is the result of an effort to identify regulatory science needs that, if addressed, would enhance CDER’s ability to fulfill its regulatory mission. The FDA Critical Path Opportunities Report and Critical Path Opportunities List, 1 published in 2004 and 2006, focused on addressing scientific challenges underlying medical product development and served as a catalyst for CDER to launch this effort. In October 2010, the FDA released “Advancing Regulatory Science for Public Health,” a document which incorporated the Critical Path objectives into a broad framework for advancing regulatory science.
2 FDA will soon be releasing a cross-cutting strategic plan for regulatory science. This CDER science and research needs document complements the strategic plan, providing additional details specific to CDER products. By communicating CDER’s science and research needs externally, CDER hopes to stimulate research and foster collaborations with external partners and stakeholders.
The document is not intended to address the clear and compelling need to maintain a robust
scientific readiness to respond rapidly to regulatory crises, such as contaminated heparin, nor does the document focus on scientific infrastructure needs being addressed through other initiatives (e.g., informatics infrastructure).
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