Biologics

Regen Centers Marketing Unapproved Cellular Products: FDA

The CBER Office of Compliance and Biologics Quality says its review of a Web site maintained by The Regen Centers, Rancho Mirage, CA, determined that the firm markets cellular products derived from human umbilical cord blood, umbilical cord tissue, amniotic membrane, or adipose tissue, which the company refers to as “regenerative medicine therapy.” The therapy is said to treat various diseases or conditions such as chronic obstructive pulmonary disease, leukemia, diabetes, heart failure, and lung and kidney diseases and disorders, according to a 7/8 Notice of Violation.

The letter says the products would be regulated as drugs and biological products and require a valid BLA or IND, which The Regen Centers does not have.

FDA also notes the company Web site lists exosomes as being used in conjunction with regenerative medicine therapy and advises the company that generally exosomes for clinical use in humans also are regulated as drugs and biological products subject to the same premarket review and approval as the cellular products.

The Regen Centers 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