FDA Policy/General

Abernathy Overhauling FDA Tech Infrastructure: Politico

Politico’s Prescription Pulse online newsletter says that FDA principal deputy commissioner Amy Abernathy has been named the agency’s acting chief information officer and begun an overhaul of its tech structure. She tells Prescription Pulse she became acting chief information officer “because it became clear that the first thing we needed to do was get our house in order from a technical perspective” to be ready for real-world data and digital health products that are on the way. She has introduced a technology modernization plan expected to require at least 12-18 months.

The newsletter reports that artificial intelligence (AI) is part of the mix and that FDA is thinking about the wide variety of technologies that it currently oversees and fast-growing fields adjacent to its jurisdiction like AI that helps curate data or does patient matching. And, Abernathy told the newsletter, FDA needs to bring its own infrastructure and AI abilities up to speed.

On another topic, she said that FDA is on schedule to release its plan to regulate cannabidiol or CBD this fall and that consumers need to understand that the fast-growing product is not totally safe. She said the country will have to deal with how much risk it is willing to tolerate from CBD.

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