Biologics

Verax Asks FDA Not to Take ‘Arbitrary’ Action

Verax Biomedical is asking that FDA:

refrain from clearing, approving, recommending, or issuing a “safety measure” designation for large volume delayed sampling (LVDS) as a single step bacterial culture technology for dating beyond Day 5 without first obtaining statistically conclusive data supporting the safety and effectiveness from clinical evidence on apheresis platelets demonstrating that the LVDS method is effective at preventing the transfusion of bacterially contaminated blood platelets by Day 5;
refrain from clearing, approving, recommending, or issuing a “safety measure” designation for any other platelet contamination detection method, storage device or method, or pathogen reduction method without statistically conclusive data supporting the safety and effectiveness from clinical evidence on apheresis platelets demonstrating that the technology or methodology is effective at preventing the transfusion of bacterially contaminated blood platelets; and
refrain from clearing, approving, recommending, or designating as a “safety measure” any technologies or methodologies without statistically conclusive data supporting the safety and effectiveness of the technologies or methodologies.

Verax says it also wants FDA to “apply consistent regulatory standards and precedents in reviewing data in support of such products or expanded claims.” It reminds the agency that a court will set aside an agency action when the action is arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.

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