FDA Policy/General

TN Man Guilty of Violating FDA Vet. Drug Reg

Billy K. Groce (Knoxville, TN) has pleaded guilty in the U.S. District Court for Western Virginia to evading FDA veterinary drug regulations. According to a Department of Justice release, evidence showed that Groce operated a business that was created for the purpose of illegally circumventing the agency’s regulation related to interstate shipment and labeling of veterinary drugs. “Groce’s business illegally obtained, stored, sold and caused to be shipped, drugs from veterinary drug manufacturers and distributers,” the government contends. Groce’s business was not a licensed wholesale, a licensed pharmacy or a veterinary clinic.

Groce reportedly shipped drugs to co-conspirator Marlin Webb, who was a store manager at the Carroll County Cooperative. Webb then illegally sold the drugs through the cooperative, the government says. Webb previously pleaded guilty to one count of conspiracy to defraud FDA and was sentenced to one year of probation and paid $125,000 in forfeiture and other payments at the time of his guilty plea.

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