Drugs

FDA Says Infuze MD Markets Unapproved Drugs

The CBER Office of Compliance and Biologics Quality says its review of the Web site maintained by Infuze MD, Milpitas, CA, determined that the firm markets “IV Stem Cell Therapy,” administered intravenously to treat several diseases or conditions. A 4/27 Notice of Violation said CBER also determined that at least one of the IV stem cell therapy products Infuze markets is derived from human umbilical cord blood, classifying it as a human cell, tissue, or cellular or tissue-based product.

Because Infuze does not qualify for any legal exception, the letter says, the umbilical cord blood product would be regulated as a drug and biological product that needs an approved BLA or IND in effect.

CBER also notes that the Web site lists exosomes as one of the “regenerative therapies” the firm offers. “Please be advised that, as a general matter, exosomes for clinical use in humans are also regulated as drugs and biological products … and are subject to premarket review and approval requirements…,” the notice says.

The letter reminds the company that it is responsible for ensuring that all of its products fully comply with applicable laws and regulations and requests a written response within 30 days.

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