Drugs

BsUFA Regulatory Research Roadmap

FDA has published a request for comment on its research roadmap for a BsUFA 3 (Biosimilar User Fee Act) regulatory research pilot program. The request for comment says the BsUFA 3 commitment letter between FDA and industry representatives that led to the reauthorization of the user fee program included a commitment for FDA to pilot a regulatory science research program to further enhance regulatory decision-making and facilitate science-based recommendations in areas foundational to biosimilar development.

The pilot program has two demonstration projects: (1) advancing the development of interchangeable products and (2) improving the efficiency of biosimilar product development.

The Roadmap highlights scientific areas where advancement is expected to impact science-based recommendations and regulatory decision-making. FDA says it is seeking input from patients, researchers, non-profit organizations, companies, and other stakeholders on the research strategy and priorities and any additional regulatory science research gaps.

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