FDA Requests Input on User Fee Program for Biosimilar and Interchangeable Biological Products

The U.S. Food and Drug Administration (FDA) announced this month that it is seeking industry and stakeholder input on the development of a user fee program for biosimilar and interchangeable biological products. Written comments must be submitted to the FDA no later than June 9, 2011. In addition to accepting written comments, the agency will be holding public and industry stakeholder meetings. Parties interested in participating in these meetings must submit a notification of interest to the FDA on or before June 3, 2011. The FDA issued a Federal Register notice on May 10, 2011, which outlines the agency’s proposals for the new user fee program and includes detailed information about how to submit comments and notices of interest.

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