Drugs

FDA Cites 2 Pharmacy Compounding Operations

Prescription Lab Compounding Pharmacy and Stonegate Pharmacy have been cited in two recent Warning Letters as part of FDA’s increased scrutiny of drug compounding operations. In a Warning Letter to Prescription Lab, the agency said it observed a serious deficiency in its practices for producing sterile drug products. Specifically, it said glass beakers used to mix non-sterile drug product solutions prior to the sterilization step are not protected from contamination after they are processed through a dry oven.

In a separate Warning Letter to Stonegate, FDA investigators noted that the firm did not receive valid prescriptions for individually-identified patients for a portion of the drug products produced. The investigators also noted that it produces domperidone products, which are not on a list recognized by the agency as approved for compounding. Additionally, they observed serious deficiencies in Stonegates’practices for producing sterile drug products. For example, the investigators noted the use of non-sterile wipes and non-sterile disinfectants in the ISO 5 area in which sterile products are processed.

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