Predicting The User Fee Reauthorization Schedule
Executive Summary
PDUFA and GDUFA negotiations are expected to begin first, as they usually take the longest to complete, and will be followed by BsUFA talks.
You may also be interested in...
User Fee Bill’s Accelerated Approval Reform Provisions Watered Down, But Could Speed Withdrawals
Withdrawal procedure in House consensus bill would require only one advisory committee hearing, instead of potentially two, likely shortening the time to a final decision.
Shared First Interchangeable Biosimilar Exclusivity May Be Allowed Under US FDA User Fee Bill
Legislation in development also could create an option for tentative approval of interchangeable biosimilars.
Shared First Interchangeable Biosimilar Exclusivity May Be Allowed Under US FDA User Fee Bill
Legislation in development also could create an option for tentative approval of interchangeable biosimilars.