FDA Policy/General

FDA Inspections Reorganization Effective 10/1

Today (10/1) marks the beginning of a new model for FDA inspections as part of a reorganization that was brought on by the 2022 infant formula debacle (see FDA Webview 1/2023 and 4/2022) FDA’s Office of Regulatory Affairs has been renamed the Office of Inspections and Investigations under the now-in-effect restructuring that is intended to revamp field operations to focus on inspections, investigations and imports as its core mission

“This is the single largest reorganization in the agency’s modern history, as it impacts more than 8,000 employees and touches almost every facet of the FDA,” an agency notice says.

On the inspection side, FDA says it has “created an enterprise-wide structure that will enhance collaboration between our field investigators and other subject matter experts throughout the agency and modernize and strengthen the entire agency to work more cohesively and collaboratively in accomplishing our collective public health mission.”

Additionally, the agency says it plans to pilot a new online consumer complaint form to “both improve the consumer experience when submitting complaints as well as internally handle complaints more efficiently and effectively, helping the FDA to better detect and respond to emerging public health risks.” For now, it appears the complaint form is not being extended to medical products. A separate notice on the reorganization was posted announcing a new, “streamlined approach for processing complaints, including whistleblower complaints, that will improve the agency’s ability to detect and respond to problems related to FDA-regulated products and better protect public health.” However, it says such a complaint must be about an “illness, injury, allergic reaction, or other health-related issue or about defects in the quality or safety of an FDA-regulated food, dietary supplement, or cosmetic product.”

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