Biologics

Pacific Stem Cells Selling Unapproved Products: FDA

The CBER Office of Compliance and Biologics Quality says that Pacific Stem Cells, Newport Beach, CA, is marketing “stem cell therapy” products for stroke, macular degeneration, Lyme disease, Parkinson’s disease, heart disease, lupus, rheumatoid arthritis, and multiple sclerosis. A 2/17 Notice of Violation says Pacific appears to administer the products by various routes, including intraorally and intravenously.

The notice says it appears that the firm’s cellular products would be regulated as drugs and as biological products. It says Pacific does not have a BLA or IND in effect for its products.

According to FDA, using the cellular products for unapproved uses raises potentially significant safety concerns.

Pacific was told to respond to the issues raised in the letter 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