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DEA Delays in Scheduling Are Offsetting FDA’s Improved Decision Making

This article was originally published in RPM Report

Executive Summary

FDA is showing a renewed commitment to meeting review deadlines for new molecular entities, but that is not translating into earlier commercial availability for all NMEs. Some products also need a controlled substance scheduling decision from the Drug Enforcement Administration; those actions have become a new regulatory purgatory that can be painful and frustrating.

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