www.fdanews.com/articles/142274-biosimilar-user-fee-program-mirrors-pdufa-includes-spa-path
Biosimilar User Fee Program Mirrors PDUFA, Includes SPA Path
December 7, 2011
The FDA’s proposed biosimilars user fee program mirrors that for drugs under the Prescription Drug User Fee Act (PDUFA), and includes performance goals for special protocol assessments (SPA) that could help ensure a clear path to approval for the generic biologics, the agency said Tuesday.
Drug Industry Daily
Drug Industry Daily