US FDA Making BsUFA III Regulatory Science Grants Available Early
Executive Summary
Up to $1m per year per award is available for projects that address significant issues with biosimilar or interchangeable product development.
You may also be interested in...
Will US FDA User Fee Deal Allow BsUFA Reg Science Research To Start?
The FDA had picked grantees for the initial round of biosimilar regulatory science research, but told them not to start major activities until the user fee reauthorization was assured. Congress now appears to have reached deal for a ‘practically clean’ reauthorization.
Senate’s US FDA User Fee Bill Answers Biosimilar Interchangeable Exclusivity Questions
The bill would allow for tentative interchangeable approvals, as well as shared first interchangeable exclusivity for multiple first filers.
Senate’s US FDA User Fee Bill Answers Biosimilar Interchangeable Exclusivity Questions
The bill would allow for tentative interchangeable approvals, as well as shared first interchangeable exclusivity for multiple first filers.