Drugs

Consent Decree Entered Against Utah Drug Outsourcer

A Utah federal judge has entered a consent decree of permanent injunction against Isomeric Pharmacy Solutions (Salt Lake City), co-owners William O. Richardson and Rachael S. Cruz, and chief operating officer Jeffery D. Brown. The court action bars them from manufacturing, processing, packing, holding, or distributing drugs until they comply with FDA’s regulations and requirements.

According to the complaint, Isomeric manufactured and distributed sterile drug products, including injectable and ophthalmic drugs that were found to be adulterated because the drugs were made under insanitary conditions and in violation of GMP requirements. It also alleges that the company manufactured and distributed unapproved drugs and drugs that were misbranded because their labeling did not bear adequate directions for use.

FDA’s latest inspection of the firm ended 3/24 that preceded a voluntary nationwide recall of all lots of unexpired drug products produced for sterile use. Inspections also occurred in 2015 and 2016, which revealed that the company had not implemented adequate corrective actions. A Warning Letter followed the 2016 inspection.

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