Drugs

FDA Information on Immune Globulin Shortage

FDA says that since the demand for immune globulin (IG) products has increased in recent years, despite supply increases, there is an ongoing shortage of IG intravenous and IG subcutaneous products in the U.S. that could affect patient care. An agency statement says that in the setting of increased demand for IG, other factors that ordinarily might not affect availability may have a greater effect. Those factors could include uneven product distribution across different localities, logistics of contractual obligations, production delays, and other factors.

The agency says that while it cannot legally require a manufacturer to begin producing, continue producing, or increase production of drugs, it does work with manufacturers whenever possible to help mitigate shortages when it learns of them. It says it is working very closely with several applicants/manufacturers to help mitigate the supply situation for IG products as best as possible, and also is working with industry to explore ways to improve the manufacturing of IG products, which are derived from donor plasma.

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