Biologics

FDA Cautions Patients, Consumers on ‘Regenerative’ Products

FDA says there continues to be broad marketing of unapproved products containing regenerative medicine therapies that are intended to treat or cure a wide range of diseases or medical conditions. In an online information sheet for patients and consumers, the agency says such products require FDA approval or licensure to be legally marketed. And before approval, the products require agency oversight in a clinical trial.

“These unapproved products, whether recovered from your own body or another person’s body, include stem cells, stromal vascular fraction (fat-derived cells), umbilical cord blood and/or cord blood stem cells, amniotic fluid, Wharton’s jelly, ortho-biologics, and exosomes,” the notice says. “FDA has received reports of blindness, tumor formation, infections, and more, detailed below, due to the use of these unapproved products.”

The notice says consumers should contact FDA if they are offered any of the products outside of a clinical trial with agency oversight or if they are considering treatment with such products and have questions. The agency also solicits adverse event reports or complaints about the products.

“If you are being charged for these products or offered these products outside of a clinical trial, you are likely being deceived and offered a product illegally,” the notice says. “Likewise, FDA is aware that patients and consumers are being referred to ClinicalTrials.gov, or are told that a product is registered with FDA, as a way to suggest that the products being offered are in compliance with FDA laws and regulations. This is often false.”

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