Biologics

‘Fresh Allograft Heart Valves’ Regulated by FDA

FDA is affirming its regulation of “fresh allograft heart valves” in a just-posted letter to healthcare professionals. The letter addresses recent questions the agency has received about the regulatory status of the allograft heart valves used in a procedure commonly referred to as “partial heart transplantation,” which involves transplantation of fresh aortic and pulmonary allografts prepared from a donor’s heart for treating irreparable congenital heart defects in neonates and infants, according to FDA.

Based on the agency’s understanding of the process, “prior to a partial heart transplantation procedure, the entire donor heart is recovered then packaged to maintain a cold environment and shipped to the transplant center,” the letter says. “Once received in the recipient operating room, the aortic and/or pulmonary valves with contiguous tissues are prepared and immediately implanted according to standard surgical technique, for example, for a double root replacement. Provided the fresh allograft heart valves used in these procedures meet all the criteria in FDA’s tissue regulations (21 CFR 1271.10(a)), they are regulated by the agency as HCT/Ps [human cells, tissues, and cellular and tissue-based products] under section 361 of the Public Health Service Act and the regulations in part 1271.”

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