Biologics

Increased Enforcement on Violative Cell/Tissue Products

FDA appears to be stepping up its enforcement efforts against violative cell/tissue products. On 12/6, the agency warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC (Yorba Linda, CA) for processing and distributing unapproved products derived from umbilical cord blood. They were warned also on current good tissue practice and GMP requirements, including deficient donor eligibility practices, inadequate aseptic practices to prevent contamination and deficient environmental monitoring, the agency says. “These deviations create potential significant safety concerns that put patients at risk,” it adds.

Earlier this month, FDA sent untitled letters to RichSource Stem Cells, Inc., and Chara Biologics over unapproved stem cell products being offered to patients. The agency says it also recently sent 20 letters to manufacturers and health care providers about offering unapproved stem cell products.

In addition, FDA recently issued a safety alert about exosome products. “Certain clinics across the country, including some that also manufacture or market violative ‘stem cell’ products, are now also offering exosome products to patients,” the agency says. “FDA’s safety alert informs the public, especially patients, health care practitioners and clinics, of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes. These reports were brought to the FDA's attention by the Centers for Disease Control and Prevention, among others, and the agencies worked with the Nebraska Department of Health and Human Services.”

FDA has reiterated its enforcement discretion policy under its regenerative medicine policy framework that runs until 11/2020 for products that do not raise safety concerns. Based on the recent Warning Letter and other correspondence, the agency says it “does not intend to exercise such enforcement discretion for those products that pose a reported safety concern.”

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