Biologics

Routine Vaccine Inspections May be Challenge: GAO

A 10/27 Government Accountability Office oversight report on the federal government response to Covid-19 says FDA “may face challenges resuming routine surveillance inspections of vaccine and allergenic manufacturing establishments.” The agency told GAO that vaccine inspections are a priority, the report says.

It says FDA significantly reduced inspections of biologic manufacturing establishments due to the Covid-19 pandemic and identified alternative tools it could use to help oversee manufacturing quality during the emergency. The alternative tools included records requests, investigations and site visits, and remote interactive evaluations.

GAO says it spoke with representatives of biologic manufacturing associations who said they generally supported the use of alternative inspection tools, although there were some challenges. The association representatives noted a lack of communication from FDA following record requests. GAO says the agency indicated it planned to revise record request procedures in FY 2022 to increase communication with manufacturers.

GAO says a major issue in resuming inspections at vaccine and allergenic manufacturing establishments is that most of them are overseas and CBER has not set a schedule for resuming foreign inspections.

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