Drugs

CAR T Cell Product Development Guidance

FDA has published a draft guidance, Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, to assist industry and academic sponsors in developing such products. The document provides CAR T cell-specific recommendations about chemistry, manufacturing, and control; pharmacology and toxicology; and clinical study design.

Recommendations specific to autologous or allogeneic CAR T cell products are noted in the guidance. It also provides recommendations for analytical comparability studies for CAR T products.

FDA says that while the guidance specifically focuses on CAR T cell products, much of its information and recommendations will also apply to other genetically modified lymphocyte products such as CAR Natural Killer cells or T cell receptor-modified T cells.

Included in the guidance are Introduction, Background, General Considerations for CAR T cell design and development, CMC Recommendations, Preclinical Recommendations, Clinical Recommendations, and References.

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