Advancing Revolutionary Therapies
Cell and gene therapies have made impressive clinical progress but continue to face big hurdles. Nothing is standard about study design, study conduct or regulatory process in this specialized area.
Advancing Revolutionary Therapies
Regulatory Considerations for Biosimilars Development in the U.S.
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ART
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Season 3
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Episode 6
The development of biosimilar products in the US has been progressing since the regulatory pathway was established as part of the Affordable Care Act. Listen as members of Veristat’s Regulatory team delve into the analytical and clinical science of biosimilars and their regulatory pathway.