Biologics

FDA Denies Cell2in Cell-Based Therapy Petition

FDA has denied a 5/20/20 Cell2in petition calling on the agency to update one or more guidance documents to identify real-time glutathione (GSH) monitoring methods as an acceptable means of measuring potency for purposes of submitting a BLA for cell-based therapies, including stem cell therapies. The 4/20 denial letter says the petition argued that FDA should encourage the use of GSH monitoring assays as potency assays for cellular therapy products in general.

The agency says it does not agree that updating its guidances to recommend the use of the assays for all cellular therapy products is warranted at this time.

“FDA encourages development and application of new, improved technologies for characterizing the biological products that we license,” the denial letter concludes, “and a BLA sponsor may choose to use a GSH monitoring assay … for a cellular therapy product, if the assay complies with applicable biologic and CGMP regulations; however, we do not believe it is necessary or appropriate to specifically mention real-time GSH monitoring assays in the referenced guidance documents at this time.”

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