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Woodcock: FDA Focused On Biosimilars Science Before Policy

This article was originally published in Scrip

Executive Summary

Under fire from lawmakers, Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, took cover by insisting the reason the agency has yet to issue or finalize some of the most important biosimilars guidance documents industry has been waiting on – specifically, those on interchangeability and labeling – is because regulators must first "get the science right."

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