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

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

More from Biosimilars

More from Biosimilars & Generics