Drugs

Valisure FDA-483 on Lab Practices Released

FDA has released a six-item Form FDA-483 that cites analytical laboratory Valisure over deficient laboratory practices after a 5/26-7/6/22 agency inspection. The inspection led to a 12/5 untitled letter involving testing issues associated with the lab, which was behind the identification of several high-profile product safety concerns (see earlier story).

The agency noted in the letter that until recently, the company’s Web site offered services including a “certification process” whereby its testing concludes whether drugs received from a manufacturer are “ready for shipment.” Following the inspection, Valisure stated that its testing is now “only for informational and marketing purpose and not for any regulatory purpose,” but the agency said in its letter that it remains concerned that drug manufacturers may rely on the lab’s services in the future to perform contract testing to fulfill GMP requirements.

The FDA-483 cited Valisure for failing to adequately validate or verify analytical methods used in evaluating pharmaceutical products. Additionally, FDA took issue with the lab for not adequately addressing out-of-specification test results; using instruments, apparatus, gauges, and/or recording devices that did not meet established specifications; and failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, and other records.

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