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Business · 24/09/2015Updated: 10/17/2026 · 1 min read

FDA Announces Public Comment Period for Study on Biosimilar Review Process

Summary

The FDA is seeking public input on the interim results of a study examining the workload volume and full costs associated with reviewing biosimilar biological product applications, as mandated by the Biosimilar User Fee Act of 2012.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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