FDA Policy/General

Human User Safety in Animal Drugs Guidance

FDA has published a guidance, Human User Safety in New and Abbreviated Animal Drug Applications, clarifying the current approaches and recommendations the Center for Veterinary Medicine (CVM) uses for human user safety (HUS) assessment and submission of HUS information to support the overall safety of proposed new animal drugs before approval. The document is intended for sponsors interested in pursuing the approval, or conditional approval, of new animal drugs, including new generic animal drugs. It addresses general principles of HUS assessment for new animal drugs, sources of data, mitigation strategies for proposed new animal drugs, potential recommendations to address HUS concerns, and how HUS information should be submitted to CVM.

The guidance includes an Introduction, Abbreviations, Background and Scope, Terminology, Principles of HUS Assessment, Sources of Information, HUS Recommendations, How HUS Information Should be Submitted to CVM, and Special Considerations for Generic New Animal Drugs (ANADA).

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