Drugs

Artificial Intelligence Platform Aiding Drug Reviews: Report

FDA says using Abbyy’s digital intelligence platform to analyze drug safety reports will save agency reviewers about 7,500 hours per year. An online GCN post says the platform transforms up to 120 fields in safety reports on potential adverse interactions during clinical drug trials into structured content that reviewers can check at a glance.

Previously, according to FDA Office of Business Informatics senior business informatics officer Justin Scott, reviewers had to manually study each of the 40,000 safety reports the agency receives each year before a drug goes on the market and review two million reports a year after it is released.

Now, he said the analysts get extracted and summarized information so “they can basically go to a series of reports, take a glance at it and understand, ‘All right, this is how many people took this product and were hospitalized, this is how many of them were hospitalized and subsequently died.” He said analysts using the platform can quickly gather high-level information “instead of having to open dozens and dozens of documents and take notes. Before, where they might get fatigued from reading all these PDFs and notes, now they have the data just presented right in front of them.”

The article says FDA worked with Abbyy to train the platform on all the ways safety reports can be structured. It says agency staff made sure it learned the exceptions and permutations that the forms might have and set up a place where anything that’s not recognized goes for additional analysis.

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