FDA Policy/General

Clinical Researchers Plead Guilty to Fraud

Two clinical research facility owners have pleaded guilty in the U.S. District Court for the Southern District of Florida to conspiracy to commit wire fraud in connection with their work on two clinical trials testing drugs designed to treat asthma. According to a Justice Department release, Angela Baquero and Ricardo Acuna owned A&R Research Group that conducted clinical trials of prospective new drugs on behalf of drug sponsors seeking FDA approval. Baquero served as A&R’s clinical research director and study coordinator. Acuna served as A&R’s regulatory and contract affairs manager.

Under their plea agreements, Baquero and Acuna admitted to conspiring to unlawfully enrich themselves by making fraudulent representations to the asthma drug trial sponsor regarding subject eligibility, and falsifying and fabricating material documents and data, including case histories, spirometry readings, and echocardiogram data. As part of the conspiracy, A&R provided fraudulent clinical research data to the drug trial sponsor and to an FDA investigator.

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