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Woodcock: Biosimilars Program Lacks Funding, Will Explode

This article was originally published in Scrip

Executive Summary

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), told lawmakers on Feb. 4 she was concerned the agency's biosimilars program "is going to explode" because it lacks funding and resources, with the anticipation the agency could be facing a multitude of applications it's unprepared to handle.

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