Drugs

CGMP Problems in Denmark’s ALK-Abello

A 3/3-14 FDA inspection at ALK-Abello A/S, Horsholm, Denmark, found deviations from current good manufacturing practice requirements in the manufacture of licensed biological drug products and intermediates, according to a 7/15 Notice of Violation. The letter says that significant violations shown on an FDA-483 included:

failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validating all aseptic and sterilization processes;
failing to routinely calibrate, inspect, or check automatic, mechanical, or electronic equipment according to a written program designed to assure proper performance;
failing to establish and follow a written testing program designed to assess drug product stability characteristics; and
failing to withhold from use each lot of components, drug product containers, and closures until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit.

The letter acknowledges the company’s commitment to take corrective and preventive actions to address the deficiencies and notes that the company provided insufficient details in its response and further information and discussion will be needed to review and assess the planned actions. The notice also notes the use of expired components in the manufacturing of Pharmalgen and asks for additional information on the company’s actions to correct that issue and prevent recurrence.

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