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CDER Brand Name Reviews: Predictability Returns To Process

This article was originally published in RPM Report

Executive Summary

FDA’s Center for Drug Evaluation & Research is now granting 86% of drug sponsors’ preferred proprietary trade names prior to launch – a significant improvement over just five years ago. Better communication between FDA and drugs sponsors – including the development of several new guidance documents – has resulted in a much more predictable review of proprietary trade names.

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