Biologics

Untitled Letter Objects to Web Claims by Cell Therapy Firm

CBER’s Office of Compliance and Biologics Quality has sent East West Health Solutions (Lake City, UT) an untitled letter based on a review of the company’s Web site, www.acueastwest.com, and other online sources. The review determined that the company was marketing unapproved cellular products derived from umbilical cord or amniotic membrane. They were sold for such diseases or conditions as: neurodegeneration, cognitive impairment, multiple sclerosis, Parkinson’s disease, amyotrophic lateral sclerosis, traumatic brain injury, concussion, autoimmune disease, Lyme disease, lung and heart disease, macular degeneration, and chronic obstructive pulmonary disease. The agency notes in the letter that East West Health administered the products intranasally, intravenously, or by injection.

The letter says that the unapproved uses raise potential significant safety concerns. “Moreover, because your products are administered by higher risk routes of administration, including intravenously and intranasally, their use, if contaminated could cause a range of adverse events,” it says. The letter asks for a response within 30 days on how the firm will ensure its products comply with the agency’s regulations.

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