Follow-on biologic user fees (clarification)
Executive Summary
Recently introduced legislation creating an approval pathway for follow-on biologics will apply user fees for such applications. Both the House and Senate versions of the "Access to Life-Saving Medicine Act" create a new subsection under Section 351 of the Public Health Service Act for follow-on biologics applications. The Prescription Drug User Fee Act applies to all applications submitted under Section 351. A previous story in "The Pink Sheet" stated that the bill was "silent" on user fees (1"The Pink Sheet" Oct. 9, 2006, p. 5)...