Biologics

CBER Laboratory Quality System Praised

CBER director Peter Marks says that the Center’s Laboratory Quality System (LQS) program is an international leader in biological product regulation based on demonstrated expertise in laboratory techniques. Writing in an FDA Voice blog post, Marks says the LQS “is the coordinated structure, procedures, processes, and resources that the Center uses to evaluate and test CBER-regulated biological products.” He says that LQS product testing supports biological product licensing, lot release, and surveillance of licensed biological products and other Center actions.

In 2010, Marks says, CBER received American Association for Laboratory Accreditation accreditation for six methods to test influenza vaccines and seven methods for evaluating blood donor screening kits. Additional methods have been accredited since then, he says. The 12/2015 accreditation renewal demonstrated the Center’s competence in 32 test methods previously accredited and added a new laboratory test evaluating a cELISA allergen test used by the Center for cat hair, ragweed, and dust mites in the new-accredited Laboratory of Immunobiochemistry, the post says.

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