Drugs

FDA Targets Docs for Biosimilar Education

FDA commissioner Scott Gottlieb and CDER associate director for therapeutic biologics Leah Christi say the agency is launching an educational campaign to inform doctors and other prescribers about biosimilars. In an FDA Voice blog post, Gottlieb and Christi say the agency researched to determine the specific areas that healthcare providers had questions about.

“These include questions about the data and information FDA reviews when it’s making decisions to approve a biosimilar,” they write. “Based on that feedback, FDA has developed educational materials to help healthcare providers gain a better understanding of these important products and the approval process they undergo. This includes fact sheets and graphics for healthcare professionals, as well as materials for organizations to use in disseminating this information to their interested members.”

The post says the materials (1) provide basic definitions of terms like biological product, reference product, biosimilar, interchangeable, and other key terms; (2) describe the standards any biosimilar must meet before approval and explain the agency approval pathway for the products; and (3) provide easily accessible information about the data and information FDA reviews to determine biosimilarity and how to find more resources.

The post, which contains a link to the educational materials, says the agency will undertake additional research with healthcare professionals to learn more about the types of information prescribers need to properly communicate with their patients about biosimilars.

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