FDA Policy/General

FDA Gains Consent Decree Against Supplement Maker

A California dietary supplement manufacturer, Custompax Inc. (Freemont, CA) and its CEO Cedric Ling have been ordered to stop selling their products until they come into compliance with FDA dietary supplement manufacturing regulations and other requirements listed in a consent decree. According to the government, Custompax manufactured and sold customized dietary supplements directly to Web sites where physicians and health care practitioners created and ordered their own unique dietary supplements by selecting the type and quantity of ingredients as well as custom labels or unique names. FDA sought an injunction over multiple GMP violations, “including the failure to adequately establish identity specifications for each component used in the manufacture of finished dietary supplements; the failure to establish component specifications to ensure the finished product meets specifications for purity, strength, and composition; the failure to establish product specifications for the identity, purity, strength, composition of the finished batch of dietary supplement; and the failure to conduct appropriate tests or examinations to determine compliance with specifications for identity, purity, strength, and composition,” an agency notice says.

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