Drugs

Researcher Convicted in FDA False Statement Case

A federal jury has convicted former Unlimited Medical Research clinical researcher Jessica Palacio (Miami, FL) for making a false statement to a government investigator related to her role in a clinical trial that studied the effectiveness of asthma drugs in children. The FDA Office of Criminal Investigations case began after an unnamed drug manufacturer identified issues in the trial performed by the company during a review of data and notified the agency.

Last year, a grand jury in Miami returned a two-count indictment against Palacio “alleging a scheme to falsify medical records to make it appear as though pediatric subjects made scheduled visits to Unlimited Medical Research, received physical exams from a clinical investigator, and took study drugs as required, when in fact these things had not occurred,” a Department of Justice release contends. “The indictment alleged that when Palacio was confronted by an FDA regulatory investigator about her role in the clinical trial conducted by United Medical Research, she made a false statement by submitting a false affidavit claiming that she had performed a screening visit of a child subject when she had not.”

Palacio is scheduled to be sentenced on 11/21.

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