Drugs

Three Charged with Falsifying Clinical Trial Data

A Miami grand jury has charged three defendants for their roles in an alleged scheme to fabricate and falsify clinical drug trial data submitted to FDA, according to a Department of Justice release. The just-unsealed indictment has charged Miguel Montalvo, Bernardo Garmendia, and Ivette Portela, all of Miami, with conspiracy to commit wire fraud and one substantive count of wire fraud, DoJ says. In addition, Montalvo was also charged with making a false statement to an FDA investigator.

According to the indictment, from 9/2015 through at least 3/2018, the three individuals fabricated clinical trial data for profit while working at AMB Research Center, a medical clinic based in Miami. It alleges that the defendants “knowingly enrolled subjects in a clinical trial even though those subjects failed to meet eligibility criteria, falsified subject laboratory results, falsified subject medical records, and falsely represented that subjects were taking the drug being studied when, in fact, they were not,” DoJ says. “Montalvo and Garmendia were co-owners of AMB Research Center, where Montalvo also served as a lead study coordinator and Garmendia served as a study coordinator. Portela worked at AMB Research Center and was a pharmacy technician.”

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