FDA's Biosimilars Meeting Management Should Improve After Reorg In New Drug Office
US FDA met more biosimilar user fee program meeting performance goals in FY 2018 compared to prior year but still fell short in scheduling for three of five types of meetings. Office of New Drugs reorganization, once completed, should address some logistical scheduling issues.
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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.
Biosimilar availability may not be in the its purview, but the FDA still is thinking about ways to help industry deal with the issue and support sector growth.
Meeting management and some application assessment changes also may be necessary as stakeholders prepare for the second biosimilar user fee program reauthorization.