Drugs

More Drug Compounding Improvements Needed: Woodcock

CDER director Janet Woodcock says that the Center’s experience monitoring pharmacy compounding since passage of the Drug Quality and Security Act “has demonstrated a need for further improvement in compounding practices.” Writing in the New England Journal of Medicine, Woodcock says that the agency has discovered problematic conditions in the vast majority of the 425 inspections of compounding pharmacies it has conducted since 2012. “Examples of observations include dead insects in compounding areas designated for sterile processing, visible mold on ceiling tiles in compounding rooms, and dog beds and dog hairs in close proximity to compounding areas,” she writes.

FDA has received reports, Woodcock says, of serious adverse events, including deaths, associated with improperly compounded drugs as recently as 2017. She noted CDER has issued draft guidance with examples of “insanitary conditions” observed in compounding facilities and actions companies should take if they identify such conditions at their facilities. It also issued draft guidance to aid compounding facilities in identifying and correcting insanitary conditions and to help state regulators assess whether the conditions they observe during inspections would be considered insanitary.

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