BsUFA III Expands Biosimilar Supplement Review Goals To Speed Approvals

 
• By Derrick Gingery

Six supplement categories based on submission content will be created with review goals between three and 10 months.

FDAEntrance_1200x675
The FDA plans to hire an additional 15 employees to help implement the BsUFA III program changes.

More from User Fees

More from Pathways & Standards