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  1. Biosimilar User Fee Amendments

Review of Biosimilar Biologic Product Applications: Study of Workload Volume and Full Costs- Interim and Final Report

As part of BsUFA, FDA was required to contract with an independent accounting or consulting firm to study the workload volume and full costs associated with the process for the review of biosimilar biological product applications. More information about the requirements for the reports are described in section 744I(d) of the FD&C Act (21 U.S.C. 379j-53(d)),[1] as amended by the Food and Drug Administration Safety and Innovation Act enacted in 2012.[2]
 

[1] This document is available on the Internet at §379j–53. Reauthorization; reporting requirements.
[2]This document is available on the internet at PUBLIC LAW 112–144—JULY 9, 2012.

 

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