Drugs

Genesis Herb Operators to Plead Guilty to FDA Charges

The operators of Genesis Herb, an Ohio dietary supplement manufacturing company, intend to plead guilty in federal court to charges of failing to register a food manufacturing facility and refusing an FDA inspection. A Department of Justice statement says Shane Cotterill, Monroeville, OH, was charged with three counts of failing to allow an FDA inspection, one count of introducing adulterated food, and one count of failing to register a food manufacturing facility. Michael Sanor, North Canton, OH, was charged with one count of introducing adulterated food and one count of failing to register a food manufacturing facility.

The statement says Cotterill initially allowed inspection of storage areas and out-buildings that contained items such as boxes, packing materials, shipping labels, and invoices, but refused on several occasions to provide access to the areas where the dietary supplements were manufactured and stored. He also allegedly refused to provide access to manufacturing records covering the operations of Genesis Herb.

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