Drugs

Woman Sentenced in Drug Trial False Statement Case

A Florida woman was sentenced to three years in prison and three years of supervised release for making a false statement to an FDA investigator related to a clinical trial that studied the effectiveness of asthma drugs in children. The Department of Justice says Jessica Palacio of Miami was sentenced in a Florida federal court.

The department says Palacio worked from 2013 to 2015 as a clinical research coordinator at Unlimited Medical Research (UMR) in Miami. It says the drug manufacturer identified issues in the trials performed by UMR based on a review of data and notified FDA.

A 5/2021 grand jury indictment against Palacio alleged a scheme to falsify medical records to make it appear as though pediatric subjects made scheduled visits to UMR, received physical exams from a clinical investigator, and took study drugs as required. None of those events had occurred, the grand jury said.

The indictment said that when Palacio was confronted by an FDA investigator about her role in the clinical trial conducted by UMR, she submitted a false affidavit claiming that she had performed a screening visit of a child subject when she had not.

Four co-conspirators have already pleaded guilty to their role in the scheme and were sentenced, the department said.

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

Read more

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