Drugs

Thermo Fisher Plant Scrutinized by FDA: Reuters

A Reuter’s look at Thermo Fisher's Greenville, NC drug contract manufacturing plant finds that it has been inspected twice this year by FDA. The most recent inspection was in May and documented manufacturing issues related to AstraZeneca/Sanofi’s respiratory syncytial virus drug Beyfortus for infants and toddlers. Asked about the inspection, both FDA and Sanofi told Reuters that the issues had been resolved.

Reuters shared 10 years' worth of FDA inspection documents referencing the facility with two manufacturing experts who questioned the company's approach to quality control. “There are multiple issues with the culture of the organization,” Parenteral Drug Association vice president David Talmage told the news organization. “They are not looking at the long term and have a fix-when-caught mentality versus a culture of prevention.”

One issue identified at the facility was how the company measured and set thresholds for bubbles that can occur in injectable medicines, which can cause deadly blood blockages in veins or arteries, according to Reuters. Former FDA Office of Manufacturing and Product Quality director and now-consultant Steven Lynn said the issues with Thermo Fisher’s monitoring of bubble size was one of the more troubling findings. Both FDA and the company acknowledged that the matter has been resolved to the agency’s satisfaction.

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