FDA User Fee Program for Biosimilar and Interchangeable Biological Product Applications
The Food and Drug Administration (FDA) published a notice on May 10, 2011 seeking comments on its upcoming user fee program for biosimilar and interchangeable biological product (351(k)) applications. The user fee program was mandated by the Biologics Price Competition and Innovation Act of 2009, which was enacted as part of the Affordable Care Act (ACA). In particular, the FDA seeks comments on the identified principles for development of a 351(k) user fee program, along with the proposed structure and performance goals for the user fee program. Comments on the notice will be accepted until June 9, 2011. The FDA plans to hold a series of industry-stakeholder meetings this year as it develops its plan; stakeholders who have not notified FDA of their interest in participating in these meetings should notify the agency by June 3, 2011.
