Drugs

FDA Warns 3 API Repackers on CGMP Issues

FDA says it has issued Warning Letters to three repackers of active pharmaceutical ingredients (APIs) for significant violations of current good manufacturing practice (CGMP) requirements. An agency news release says the letters went to B&B Pharmaceuticals, Inc. and Asclemed USA, Inc., doing business as Enovachem and Spectrum Laboratory Products, Inc.

The letter to B&B described failure to conform to CGMPs, including failing to thoroughly investigate complaints regarding sub-potent APIs. The repacker also failed to conduct cleaning validation studies to demonstrate that cleaning procedures for non-dedicated product equipment are adequate to prevent potential cross-contamination between repackaged APIs, including highly potent drugs such as testosterone, progesterone, estrogen, and opioids, FDA says.

The letter to Enovachem cited, among other violations, failing to maintain traceability of the APIs through the supply chain and distributing APIs including opioids, to customers with incomplete certificates of analysis.

The Spectrum Warning Letter said the company repackages various opioid APIs but did not provide complete information in its certificates of analysis provided to its customers, including compounding pharmacies.

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