CBER Untitled Letter Over Unapproved Cellular Product

CBER has issued an untitled letter to Laguna Beach Aesthetics, Cosmetic Dermatology and Laser Center (Laguna Beach, CA) over its unapproved cellular product derived from adipose tissue that is marketed to treat various diseases or conditions, such as cancer, chronic pain, cerebral palsy, cystic fibrosis, diabetes, epilepsy, fibromyalgia, heart disease, kidney disease, liver disease, multiple sclerosis, muscular dystrophy, Parkinson’s disease, and spinal cord injuries.

The letter says the biological product requires a valid biologics license. The unapproved product’s intended uses “raise potential significant safety concerns,” it says. “Moreover, because your product is administered by a higher risk route of administration, its use, if contaminated could cause a range of adverse events.”

CBER told the company to provide a written response on how it will comply with the FDA regulations.