Biologics

Optimal Health Selling Unapproved Cellular Products: FDA

FDA says its review of the Web site and YouTube channel maintained by Optimal Health Stem Cell and Wellness Institute, Appleton, WI, indicates that the firm markets cellular products derived from human umbilical cord, adipose tissue, and amniotic membrane. A 10/1 Notice of Violation says that to lawfully market such products, a company must have a valid BLA or IND in effect.

“Your products derived from human umbilical cord, adipose tissue, and amniotic membrane are intended to treat a variety of diseases or conditions, including some that are severe or life-threatening,” the letter says. “Such unapproved uses raise potential significant safety concerns. Moreover, because at least some of these products are administered by higher-risk routes of administration, including intravenously and intrathecally, their use, if contaminated, could cause a range of adverse events.”

FDA reminds the company it is responsible for meeting all statutory and regulatory requirements and asks for a response to the findings in the letter.

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

Read more

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