Drugs

FDA Drug Inspections Slow to Recover: Analysis

A ProPublica report says FDA has been very slow to ramp up domestic and foreign drug manufacturer inspections following the Covid-19 pandemic. “Three years after the pandemic started, FDA has been slow to return to pre-pandemic inspection rates,” the analysis says. “The pandemic heightened the urgency surrounding FDA’s drug inspection process, as the need for more equipment, vaccines, and antiviral medications, many of which are produced overseas, increased.”

Citing the recent deaths linked to tainted eyedrops that were produced in India, ProPublica says its analysis of FDA inspection data shows that inspections of overseas manufacturers, mostly in India and China, have “dropped precipitously even as the number of manufacturers has remained relatively steady…. FDA … has acknowledged that limited resources make it impossible to inspect every plant, whether in the U.S. or not, that makes drugs or their ingredients. But the agency has been slow to make improvements.”

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