Biologics

Osteoarthritis Product Development Guidance

FDA has published a draft guidance, Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment, to assist sponsors who are developing medical products to treat the underlying pathophysiology and structural progression of osteoarthritis. The document says that approvals for osteoarthritis to date have been based on patient-reported outcome measures that assess pain and function. However, it says, treatments that inhibit structural damage or target the underlying pathophysiology associated with osteoarthritis remain elusive and represent an unmet medical need.

“This draft guidance is intended to serve as a focus for continued discussions among FDA, sponsors of medical products, the academic community, and the public regarding the assessment of structural endpoints,” FDA says.

The guidance does not contain discussion of the general issues of statistical analysis or clinical trial design. FDA says those topics are addressed in two International Conference on Harmonization guidances.

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