Biologics

Dahlia Center Offering Cellular Product to Treat Covid-19: FDA

The CBER Office of Compliance and Biologics Quality says its review of a Web site and Facebook page maintained by The Dahlia Center, Medina, OH, indicates that the company offers a cellular product derived from umbilical cord to treat Covid-19 or to prevent Covid-19 associated respiratory conditions via intravenous administration. A 7/15 Notice of Violation says the firm also markets “umbilical stem cells” that appear to be cellular products derived from human umbilical cord or human umbilical cord blood. Dahlia markets the products for diseases or conditions such as leukemia, prostate cancer, diabetes, Parkinson’s disease, cerebral palsy, Alzheimer’s disease, multiple sclerosis, macular degeneration, chronic obstructive pulmonary disease, lupus, congestive heart failure, Guillain-Barré syndrome, and Ankylosing spondylitis, the letter says.

Such products are regulated as drugs and biologics, CBER says, and can’t be marketed without a valid BLA or IND, which the company does not have.

The Dahlia Center was given 30 days to respond to the notice.

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