Drugs

FDA Evaluating Mass Spectrometry in Drug Quality Control

An online FDA drug science research report says the agency is evaluating an approach to use mass spectrometry to ensure the quality of complex protein therapeutics to treat cancer and other diseases. The document says that recent development of a multi-attribute method (MAM) has allowed mass spectrometry to be introduced to the quality control environment of manufacturing facilities.

CDER researchers developed an in-house MAM platform to evaluate the method and determine its suitability for quality control in the manufacture of protein-based products, the report says. They studied U.S.-approved or foreign-sourced rituximab (Roche’s Rituxan), a therapeutic antibody used to treat certain immune system disorders, including some forms of lymphoma.

“The researchers found that MAM successfully distinguished between the domestic and foreign products and could also distinguish lot-to-lot differences in the relative abundance of important product quality attributes,” the report says. “These findings suggest that MAM might be used to test the stability of drug products. Further studies are planned to evaluate MAM for assessing long- and short-term stability relative to traditional methods.”

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