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FDA's Outlook on the Drug Approval Drought

This article was originally published in RPM Report

Executive Summary

You would have to go back a quarter century to find a year with as few new drug approvals as 2007. There may be no one more concerned with the sinking approval rate of new molecular entities than FDA's Office of New Drugs Director John Jenkins. The RPM Report asked Jenkins why the stream of NMEs coming on to the market has slowed to a trickle.

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