FDA Policy/General

FDA Gets HHS Grant to Expand CURE ID Platform

FDA’s Office of Medical Policy clinical methodologies group has received a $9.2 million HHS grant to fund expansion of the CURE ID platform to allow automated data collection from electronic health records worldwide and clinical disease registries for Covid-19 and other difficult-to-treat infectious diseases. An agency statement says CURE ID is a Web-based platform and mobile app that allows the global clinical community to share novel uses of existing drugs for challenging infectious diseases. It was developed by FDA and the National Institute of Health’s National Center for Advancing Translational Sciences.

The statement says that over the next two years the clinical methodologies group will work with hundreds of medical institutions to expand CURE ID to include electronic health records and registry data. As part of the expansion, the group will work with John Hopkins staff to develop a tool to automate the extraction of data elements from electronic health records and registries into the CURE ID case report form. This infrastructure is being built for Covid-19, FDA says, but is also designed for future outbreaks of existing and emerging infectious diseases.

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