Drugs

Guilty Plea in Dietary Supplement Case

The Justice Department says Gao Mei Fang (also known as Amy Gao), of Shanghai, China, pleaded guilty to mail fraud and smuggling charges in connection with a scheme to sell mislabeled dietary supplements. An agency news statement says Gao was the supply chain manager for Genabolix USA and Shanghai Yongyi Biotechnology Co, two Chinese firms that sell raw ingredients for use in dietary supplements.

According to a 10/2017 indictment, Gao admitted that she agreed to help sell synthetic stimulant ingredients, including 1,4-DMAA, to a purported dietary supplement manufacturer in the U.S. She and two co-defendants reportedly agreed with a confidential government informant to either mislabel the synthetic ingredients or otherwise help to hide the true nature of a proposed dietary supplement from retailers. Gao admitted she knew that major American dietary supplement retailers would refuse to carry supplements known to contain certain stimulants, such as DMAA.

Gao also admitted to making false statements to FDA’s import division about a shipment of synthetic stimulants entering the U.S. She faces a statutory maximum sentence of 20 years in prison on both the mail fraud and smuggling counts.

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