Devices

Import Alert Against China Syringe Maker

In the latest move by FDA in its ongoing investigation into the quality of syringes made in China, the agency is announcing expanded actions against Jiangsu Shenli Medical Production Co. Ltd. with an additional import alert for not meeting device quality system requirements. The import alert is intended to prevent all plastic syringes distributed by this manufacturer from entering the U.S.

FDA began its investigation late last year, which is described in a related safety communication, on potential device failures with certain plastic syringes made in China. “The FDA previously received information about concerns with the performance and safety of these syringes, including their ability to deliver the correct dose of medication when used alone or with other medical devices such as infusion pumps,” the agency says.

Last month, FDA issued three Warning Letters to Jiangsu Shenli Medical Production Co. Ltd, Medline Industries and Sol-Millennium Medical. “All three Warning Letters describe violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by the FDA for use in the U.S.,” an FDA release said at the 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