Biologics

Appeals Court Backs FDA in Stem Cell Case

The 11^th Circuit Court of Appeals has upheld a Florida federal court decision to grant summary judgment to FDA in its suit alleging that US Stem Cell Clinic, its parent company, and its chief scientific officer are providing stem cell procedures that violate the Federal Food, Drug, and Cosmetic Act. The appeals court says the company procedure involved removing fat tissue from a patient, isolating the portion containing stem cells, and injecting that portion back into the patient, purportedly to treat many chronic conditions, from pain to Parkinson’s disease.

The district court enjoined the clinic from offering its procedure until it demonstrated to FDA that the therapy is safe and effective.

In its appeal, the clinic maintained that it is exempt from regulation because its procedure falls into one of two exceptions in the law.

“We disagree,” a three-judge appeals court panel wrote. “The procedure does not fall within the first exception because the biological material implanted into the patient is not the same as that removed, and the procedure does not fall within the second exception because the clinic intends the stem cells to perform functions after the procedure beyond the basic function the stem cells performed prior to the procedure.”

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