Drugs

Consider New Approach to Monitor Drug Quality

University of Kentucky researchers say FDA, large buying groups, and the Defense Department should consider alternative strategies the researchers have developed for monitoring drug quality. Writing in the Journal of Pharmaceutical Innovation, the researchers say that since FDA began monitoring the quality of pharmaceutical manufacturing by enforcing current good manufacturing practices roughly 60 years ago, forces related to the global economy have changed, making the task of monitoring quality more difficult.

“Alternative strategies by groups like Valisure and the University of Kentucky Drug Quality Study to monitor the quality of the currently circulated U.S. drug supply through end-product testing and screening have resulted in several concerning findings,” the article reports.

The researchers say the efforts of Valisure and the university create a level of tension between the medical community, the U.S. public, and FDA. “There is no doubt that FDA is still the preeminent regulator of drug quality in the world and that patients should continue to take their FDA-approved medications as prescribed by their providers,” the article says. “However, findings from these two groups support the idea that some level of introspection on modifying the approach for assessing drug quality is needed within the agency.”

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