FDA Policy/General

FDA Enterprise Data Implementation Roadmap Coming

FDA says it will roll out this year its Enterprise Data Implementation Roadmap to shape the agency’s future by delivering successful cross-agency efforts that optimize shared business processes, enhance operational efficiency and use of data while strengthening the alignment between agency-wide strategic objectives and investments. In an FDA Voices online post, commissioner Robert Califf and chief information officer Vid Desai review the agency’s progress in the effort that was started in 2021 to modernize and enhance FDA’s use of technology. “The effort provides a framework for us to take a collaborative, centralized approach to modernizing our technical IT infrastructure and the way we manage data across FDA,” they write.

Califf and Desai say their Modernization in Action report “provides a detailed review of our progress as we move closer to the speed of industry in streamlining workflows, reducing the cost of maintaining data and network security, and improving the timeliness of delivery of services.”

Califf and Desai write that when FDA applies more advanced technologies to its work, it can help facilitate innovative development of FDA-regulated products and new methods of generating and analyzing data to evaluate whether the products meet the FDA standards that patients depend on.

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