FDA Policy/General

FDA Wants to Build Medical Data Enterprise

FDA commissioner Scott Gottlieb says the agency’s FY 2019 budget request includes a $100 million medical data enterprise proposal to build a modern system that would rely on the electronic health records from some 10 million lives. Writing in an FDA Voice blog post, Gottlieb says the new system “would expand the data enterprise that we already maintain by incorporating new information from electronic health records, and other sources that would allow us to more fully evaluate medical products in the post-market setting. This is the next evolution in the agency’s development of a comprehensive data enterprise to improve medical product regulation and better inform us on the safety and benefits of new innovations.”

Gottlieb notes that real-world data can come from many sources, and it’s important that all the sources be able to communicate electronically, requiring interoperability and eliminating silos. “The FY 2019 budget request seeks to establish these building blocks, and assemble the data into an interoperable platform,” Gottlieb says.

Part of the investment also will go toward building new capabilities to assemble real-world data into formats to make the information more accessible, he says. The agency’s ultimate goal is to have such a tool become a national utility that can be accessed by qualified research partners to inform a host of important clinical questions.

Gottlieb writes that development of the new tool can make the entire clinical trial process much more efficient and can enable enrollment of more patients from diverse backgrounds into trials.

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