Drugs

FDA Seeks Computational Algorithms for Adverse Events

FDA is seeking outside groups or individual data scientists for the development of computational algorithms to identify adverse event anomalies in open FDA adverse event data available on its openFDA platform. “Automated adverse event anomaly detection would augment the traditional data mining and case review approach by enabling the unsupervised identification of novel potential safety signals,” an FDA notice says. Under this “FDA Open Data Challenge,” the agency says such algorithms should detect anomalies automatically and without the use of known anomaly labeled training data.

The notice says that FDA staff experts will review submissions, which are due by 2/29. “Submissions will be judged based on the: impact to public health, potential to inform FDA post-market surveillance, novelty of the anomalies detected, reproducibility of the results, and generalizability of the algorithm,” it says. Some participants may also be invited to discuss their submission 3/27 at the agency’s Modernizing FDA’s Data Strategy public meeting that will focus on approaches to data quality, data stewardship, data exchange, and data analytics.

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