Drugs

FDA Developing New Drug Safety Tools: Dal Pan

FDA says it is developing new processes to help identify drug postmarket safety issues. For example, the agency’s Sentinel Initiative is using the FDA Sentinel Innovation Center (IC), to test “machine learning and natural language processing technologies to more effectively access and integrate data in clinical narratives for safety studies,” CDER Office of Surveillance and Epidemiology director Gerald J. Dal Pan says in an online post.

“Through a series of methodological and infrastructure development projects, FDA has developed capabilities to conduct signal identification analyses in the Sentinel System to complement data from FAERS [FDA Adverse Event Reporting System],” Dal Pan writes. “The analytic packages and results from these projects are available on the Sentinel Initiative Web site.” The Sentinel System uses real-world data from administrative claims databases and electronic health records on medication usage and medical diagnoses involving over 300 million people in the U.S. to obtain evidence about adverse drug reactions.

Additionally, Dal Pan highlights CDER’s Newly Identified Safety Signal process, a postmarket safety initiative, which “allows for a standardized, interdisciplinary approach to systematically identify, evaluate, and address safety signals. The agency is also implementing natural language processing and machine learning methods to improve review and analysis of FAERS data and is exploring applying these techniques to the medical literature.” He points to an Information Visualization Platform (InfoViP) as an example of a decision-support software tool that will allow safety reviewers to “focus on evaluating complex data and detecting safety concerns.”

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