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Has FDA Reached A "New Normal"? Parexel Thinks Lower Review Metrics May Be Here To Stay, Though FDA Hopes To Improve

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Shortly after the third anniversary of the FDA Amendments Act, the repercussions of FDA's new authorities and responsibilities for drug review performance are becoming clearer

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The rate of first-cycle approvals of new molecular entities in 2010 eclipsed previous highs, suggesting that the regulatory innovations of the FDA Amendments Act are paying off in terms of review efficiency.

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