Drugs

Petition Seeks Change on Probiotic Quantitative Labeling

The International Probiotics Association has petitioned FDA asking that it amend its regulations to require the quantitative amount of probiotic ingredients in a dietary supplement to be presented in terms of colony forming units (CFUs) instead of by weight. “The amendment to the regulations requested here would help ensure that consumers have the most useful, relevant information with respect to the amount of probiotic ingredients indietary supplements,” the petition says. “For other dietary ingredients that are live microorganisms, the quantitative amount shall be presented in terms of the minimum number of CFUs per serving at the end of the product's shelf life,” it says.

The group says that information about the weight of probiotics in a dietary supplement is irrelevant with respect to determining the amount of live, active organisms in the product. “The weight of the ingredient does not indicate viability at all,” it says. “Due to various cell concentrations of the probiotics, the same number of milligrams could represent very different CFU counts. hence, declaring probiotic ingredients by weight does not provide consumers with relevant information on the amount of effective ingredient they are consuming in a dietary supplement.”

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