BsUFA III: Could Regulatory Science Research Emerge With Other Tweaks?
Meeting management and some application assessment changes also may be necessary as stakeholders prepare for the second biosimilar user fee program reauthorization.
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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.
Both sides want enhancements to deal with growth in cell and gene therapy, as well as work on regulatory decision tools and finance issues.