Biologics

FDA Update on Bone Matrix TB Issue

FDA says it is working closely with the Centers for Disease Control and Prevention to investigate reports of a tuberculosis (TB) outbreak caused by Mycobacterium tuberculosis that appears to be linked to a bone matrix product. An agency online post outlines risk mitigation strategies for human cell, tissue, and cellular and tissue-based product (HCT/P) establishments.

The post says the HCT/P establishment’s responsible person under regulations must determine and document the eligibility of a cell or tissue donor.

Although tuberculosis may be undiagnosed due to the lack of clinical suspicion, inherent diagnostic difficulty, and/or attribution of a group of symptoms to alternate causes, FDA lists factors it says establishments may want to consider regarding HCT/P donors.

The agency also says that although there are currently no FDA-licensed, cleared, or approved donor screening tests available with an indication to screen HCT/P donors for evidence of active TB or latent tuberculosis infection, FDA is evaluating the risks and appropriate mitigation strategies, including testing.

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