FDA Policy/General

400 Unpaid FDAers Come Back to Conduct Inspections

FDA has ordered about 400 inspectors and support professionals to return to their posts from furlough to re-initiate high-risk surveillance inspections across food and medical product programs. In a series of tweets, commissioner Scott Gottlieb said about 100 staff are focused on inspections of high-risk medical device manufacturing facilities; about 70 staff are focused on inspections of high-risk drug manufacturing facilities; and about 90 staff are focused on inspections of high-risk biological manufacturing facilities.

Gottlieb noted that few inspections had been conducted since the shutdown began last month, mainly because of the holidays, and only a small number were scheduled for last week. He insisted that the shutdown has not affected many scheduled inspections. HHS and the Trump Administration recently approved his plan to begin the high-risk inspections, he said.

Meanwhile, Gottlieb noted that the drug user fee program now has about five weeks left of resources, instead of the four weeks he earlier had estimated. “This could change, but not by more than plus or minus a week,” he said. “We’ve stretched our resources by lowering burn by basically deferring internal operating charges and shifting money to salaries.” He added that similar steps on medical device user fee resources are occurring that will give the program about three months of operating resources.

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