Drugs

FDA Needs Inspection Staff Recruitment Plan: GAO

Speaking on a Government Accountability Office (GAO) podcast, GAO healthcare director Mary Denigan-Macauley says FDA needs to have a plan to address all of the causes that make it difficult to recruit facility inspectors and a strategy for retaining new hires. The podcast focuses on foreign and domestic facility inspections and makes the point that in-person inspections still have not returned to pre-Covid levels.

Denigan-Macauley says the agency will continue to rely on several alternate approaches to in-person inspections.

She says GAO has had longstanding concerns about FDA’s ability to retain its workforce. “It’s for that reason that we have put them on the High Risk list,” Denigan-Macauley says, “saying their oversight of medical products is in jeopardy because of their inability to retain that workforce. So the High Risk list is our way of putting issues that we have concerns about duplication, overlap, and fragmentation for issues that are of high criticality. In our case, it’s actually about transformation. We would like to see a transformation of how FDA oversees the medical products.”

GAO's full report can be read here.

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