Drugs

Probation for Unapproved Drug Distribution Conspiracy

A 74-year-old Georgia man who operated an Internet pharmacy on several Web sites has been sentenced to five years of probation for conspiracy to distribute unapproved drugs and unlawful smuggling of goods into the U.S. A Department of Justice statement says the sentence also included the forfeiture of over $440,000 and two properties.

Court documents and statements made in court indicated that George Kuiper sold over 100 products on his Web sites between 2006 and 2020, including prescription drugs and controlled substances that he obtained from foreign sources.

The department says his best-selling product was modafinil, a Schedule IV controlled substance and prescription new drug that is not approved by FDA. Kuiper’s Web sites were not registered with the DEA to distribute controlled substances.

Kuiper had pleaded guilty 1/14.

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