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The FDA guidance provides an explanation of changes to user fees under the Biosimilar User Fee Amendments of 2017 under Title IV of the FDA Reauthorization Act of 2017.
FDA published final guidance on Jan. 23, 2020 that provides information regarding FDA’s implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA II) under Title IV of the FDA Reauthorization Act of 2017. The guidance details the new fee structure and types of fees created as a result of BsUFA II.
Specifically, the guidance explains the process for submitting payments, the consequences for not paying BsUFA fees, and how to request reconsideration of a user fee assessment. FDA also describes how it determines which products are subject to fees. It does not, however, address how the agency determines and adjusts fees each fiscal year or how it addresses implementation of other user fee programs.