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Senior Manager, Parexel Meeting Services - Engaging Events, Simplified

In this edition of the Parexel's New Medicines, Novel Insights newsletter, regulatory experts Cecil Nick and Kurt Brorson, Ph.D., analyze how the FDA’s prior practices shaped this policy change regarding comparative data to support biosimilar switching. Learn about the impact of the new draft guidance for biosimilar developers, with practical applications that have contributed to the evolving regulatory policy on interchangeability. Read the full article below and subscribe to stay updated on the latest #NovelInsights #Biosimilars #FDA #Regulatory

New Medicines, Novel Insights: New FDA draft guidance: Implications for simplifying interchangeability for biosimilars in the US

New Medicines, Novel Insights: New FDA draft guidance: Implications for simplifying interchangeability for biosimilars in the US

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