Drugs

New Biosimilar User Fees Explained

FDA has issued a guidance, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017, to give stakeholders information on the agency’s implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA 2). The document describes the types of user fees authorized by BsUFA 2, the process for submitting payments to the agency, the consequences for failing to pay BsUFA fees, and the process for requesting a reconsideration of a user fee assessment.

The guidance also describes how FDA determines which products are subject to a fee and discusses changes to agency policy under the new law. It does not address how FDA determines and adjusts fees each fiscal year, nor does it address the agency’s implementation of other user fee programs such as PDUFA or GDUFA.

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, and Other Resources.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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