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BsUFA III: Sponsors Want Formal Meetings That Don’t Require Product Analytic Data

 
• By Derrick Gingery

An early meeting option is needed so sponsors can discuss clinical trial endpoints and similar issues before analytic data is available, industry tells the US FDA.

Business people looking at screen during video conference in office
Eliminating the analytical data requirement for some formal meetings could minimize the number of meetings needed later, one industry representative said. • Source: Shutterstock

Biosimilar sponsors want advice from the US Food and Drug Administration at early stages of development to better chart a product’s direction, but without the extensive data requirements.

During the kick-off meeting for reauthorization of BsUFA, several industry representatives requested establishment of a meeting option as part of the next iteration of the biosimilar user fee program that would allow discussions of clinical trial endpoints and

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