Drugs

House Republicans Want GAO Lab Safety Review

The Republican leadership of the House Energy and Commerce Committee is asking the Government Accountability Office (GAO) to “examine the structure of laboratory safety programs” at FDA, the Centers for Disease Control (CDC), and the National Institutes of Health. An 11/12 committee statement (includes a link to a letter to GAO) says, “The committee remains concerned about the effectiveness of the oversight HHS and its agencies provide to the laboratories they own and operate. In addition to numerous GAO recommendations that remain unimplemented by FDA, both FDA and CDC announced organizational reforms to their laboratory safety and security functions, and it is not clear whether these changes will strengthen oversight or create new undue risk.”

The letter says an FDA reorganization that brought several laboratories within the Office of the Chief Scientist “raises potential independence concerns, as FDA’s laboratory safety and security functions report to the same office.”

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