Devices

FDA Warns 2 Chinese Labs About Data Concerns

FDA has sent Warning Letters to Mid-Link Testing Company in Tianjin, China, and Sanitation & Environmental Technology Institute of Soochow University in Suzhou, China, about laboratory oversight failures and animal care violations. An agency statement (contains links to the letters) says the firms provide third-party testing and validation data services to medical device manufacturers for use in their premarket device submissions to FDA. It says the violations “raise concerns about the quality and integrity of data generated by the labs.”

The statement says the agency inspected the two firms earlier this year and found pervasive failures with data management, quality assurance, staff training, and oversight. “The findings included the failure to accurately record and verify key research data,” FDA says, “which brings into question the quality and integrity of safety data collected at the facilities. These failures could lead to the use of unreliable data in premarket device submissions. The Warning Letters also note violations related to test animals. One firm is cited for failing to provide adequate care for the animals, and both firms failed to provide adequate identification and recording of the animals used in the labs’ testing.”

The companies were told to respond with a list of specific actions they were taking to address the violations.

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