Biologics

Progress in CBER Stromal Cell Research

CBER researchers say they have demonstrated unexpected changes in the shape and size of multipotent stromal cells (MSCs) when preparations of the cells interact with specific engineered culture systems. An FDA news release says the finding is a step toward understanding how to accurately interpret studies that use such systems, known as microfluidics platforms, so they can support development of safe and effective medical products based on MSCs.

MSCs can give rise to tissues such as cartilage, bone, or fat after being stimulated to differentiate by substances called growth factors, FDA says. Their ability to differentiate has generated interest among researchers in using them to regenerate tissues and to treat various diseases or medical conditions.

Previously, FDA scientists showed it is possible to predict the behavior of stimulated MSCs by studying changes in their size and shape.

The agency findings are important, the release says, because scientists need to understand interactions between cells and materials used in microfluidic systems. Those findings are expected to enable rigorous and meaningful microfluidics system data to be used by both industry and FDA in facilitating development of MSC analysis and manufacturing using microfluidics.

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