Drugs

Sterile Drug Production Issues at Innoveix: FDA

A 5/11-5/27/21 FDA inspection at Innoveix Pharmaceuticals, Addison, TX, found serious deficiencies in the production of sterile drug products that put patients at risk. A 1/26 Warning Letter says the agency investigator found that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, which may have led to them becoming contaminated with filth or rendered injurious to health. The letter gives seven examples of adulteration.

FDA acknowledges the firm’s voluntary recall of two compounded drug products due to a lack of sterility assurance. It says some of the firm’s responses to the inspection findings appear to be adequate, but other responses could not be evaluated because Innoveix did not provide sufficient information or include documentation.

Innoveix was told to take prompt action to correct the violations and prevent their recurrence, and to respond with a list of specific actions it has taken to correct the violations, documentation of each action, and a timetable for completing the corrections.

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