Good Review Management Guidance To Be Tested By “Root Causes” Analysis
Executive Summary
FDA will evaluate the impact of its Good Review Management Principles project through a prospective analysis of NME submissions, beginning with fiscal year 2005
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As FDA rolls out its Good Review Management Principles - its attempt to improve FDA's timely review of drug applications through professional best practices - the agency is stressing the importance of sponsors submitting complete applications to facilitate this process
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