Drugs

CGMP Deviations at Mexican Signa Facility

A 12/16-12/20/19 FDA inspection at the Signa SA de CV facility in Toluca De Lerdo, Mexico, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A 7/14 Warning Letter says the specific violation was failing to adequately investigate out-of-specification results and to implement appropriate corrective action.

The letter acknowledges that Signa initiated efforts to remediate and improve its investigation programs and says the company response lacked adequate details on the remediation approach and the scope of its assessment was insufficient.

FDA notes that it cited similar CGMP deviations at other facilities in the Canadian company’s network and said the repeated failure at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate.

Signa was told to respond with a list of specific steps taken since the inspection to correct the deviations and prevent their recurrence, with a schedule for completing the steps.

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