Drugs

CDER Posts Annual Office of Compliance Report

CDER has published its Office of Compliance (OC) Annual Report for fiscal year 2022. The report says OC relies on three strategic priorities to guide decision-making in support of its mission. The first priority is to promote compliance by proactively promoting compliance through communication with stakeholders, including through publishing policy documents, engaging regularly with members of industry, and conducting training programs and conference presentations.

The second priority is the use of risk-based approaches to take compliance and enforcement actions that have the greatest impact on public health. “In FY22, we issued 101 Warning Letters across our compliance programs, obtained two consent decrees of permanent injunction, and classified 343 recall events involving more than 1,500 products,” the report says.

The third priority is operational excellence to increase efficiency and streamline operations. The report says focusing on this will help the OC be prepared to respond to emerging and existing public health threats, including supporting development of new therapies, ensuring availability of critical medications, and protecting the public from potentially harmful products. The OC also plans to fully implement and operationalize requirements under the Drug Supply Chain Security Act.

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