Drugs

AllTrials Flagging Late Trial Results

AllTrials says its online clinical trial tracking tool will begin flagging clinical trials that have reached the 13-month FDA Amendments Act of 2007 (FDAAA 2007) limit without posting trial results and the fines those companies should be paying. In an open letter to FDA commissioner Scott Gottlieb, AllTrials says that under the 2007 law, the agency has the power to sanction those who fail to meet clinical trial deadlines, including fines of up to $10,000 per day.

“Since 2014, AllTrials has been asking FDA to censure these sponsors,” the letter says. “FDA has assured us, publicly and privately, that new clarifying rules — the FDAAA Final Rule — will help you do so. Relevant trials have 13 months from completion to post summary results and adverse event information. On 2/17, it was 13 months since the FDAAA Final Rule. To avoid further delay in identifying missing trial results … our new tracking tool will start publicly flagging sponsors and trials that breach the reporting deadline.”

The group says the tracking tool will identify trials that are subject to FDAAA 2007 as they reach 13 months from completion date and flag missing results. “As the list grows each week,” it says, “the Web site will show a ranking of the sponsors with the most trials that appear in the data to be in breach of the law. It will also display an estimate of the total amount in fines that FDA could levy in response to these breaches.”

AllTrials says it knows that FDA takes patient safety seriously and will follow the tracker to act on unreported trials. To be even more helpful, it says, AllTrials will write to the agency weekly with the list of trials that have breached their reporting requirements and a rolling total of the fines that they should incur.

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