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FDA’s Drug Review Challenge For 2013: Managing Sponsor Expectations

This article was originally published in RPM Report

Executive Summary

The first late-cycle meetings under FDA’s new drug review process are scheduled to start in February, and the agency is scrambling to manage expectations. What agency officials don’t want: a contentious fight over approvability, followed by a flood of new submissions and appeals. Industry’s response: Good luck with that.

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PDUFA V and Investor Communications

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