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FDA Working 'Very Hard' To Get Biosimilars Guidances Completed, CDER Chief Tells Hearing

This article was originally published in SRA

Executive Summary

Under fire from lawmakers, Janet Woodcock, director of the US Food and Drug Administration'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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