Drugs

BsUFA User Fee Assessment Guidance

FDA has published a guidance, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017, to give stakeholders information on FDA implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA 2), which created changes to the user fee program. The document explains the new fee structure and the types of fees for which entities are responsible.

The guidance describes the types of user fees authorized by BsUFA 2, the process for submitting payments to FDA, the consequences for failing to pay BsUFA fees, and the process for requesting a reconsideration of a user fee assessment. It also describes how the agency determines which products are subject to a fee and discusses certain changes to its policies under the new law.

The guidance does not address how FDA determines and adjusts fees each fiscal year and also does not address its implementation of other user fee programs.

Included in the guidance are Introduction, Background, Definitions, Changes to the Structure of the BsUFA User Fee Program, Biosimilar Biological Product Development Fees, Biosimilar Biological Product Application Fees, Biosimilar Biological Product Program Fees, Failure to Pay Fees, Payment Information and Procedures, Appeals Process, Other Resources, and Paperwork Reduction Act of 1995.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome