Drugs

Jail for 2 Women in Clinical Trial Data Case

Two women who worked for Tellus Clinical Research in Miami, FL, have been sentenced by a Florida federal judge to terms in prison for their part in a conspiracy to falsify clinical trial data. A Justice Department statement says Analay Rico, Fort Lauderdale, a lead study coordinator, was sentenced to 40 months in prison, while Daylan Diaz, Miami, a research assistant and assistant study coordinator, was sentenced to 24 months in prison. The court also ordered the two to pay about $2.1 million in restitution.

As part of their plea agreements, the department says, Rico and Diaz admitted they agreed with others to defraud clients paying for clinical trial work intended to evaluate treatments for various medical conditions including opioid dependency, irritable bowel syndrome, and diabetic nephropathy. Among other things, the statement says, the two admitted they falsified data to make it appear as though subjects were participating in a clinical trial.

Three co-conspirators previously pleaded guilty and have been sentenced for their roles in the conspiracy, the department says.

FDA’s Office of Criminal Investigations investigated the case.

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