FDA Policy/General

Abernathy Promotes Modern IT for Product Review

FDA principal deputy commissioner Amy Abernathy tweeted 9/16 that within a month the agency will be rolling out a plan to modernize its information technology approach for its regulatory mission, including reviewing medical product applications. She previously has said this will include modernization of FDA infrastructure to make sure it can support emerging uses of artificial intelligence, blockchain, and other technologies.

“We are excited to modernize FDA infrastructure to ensure that we can support emerging uses of technology, including advances in the way that we receive, exchange and use data at FDA,” Abernathy said on Twitter. “We will be ramping up activities that update how we work with the stakeholders across this community.”

Speaking last month at the National Coordinator for Health IT Third Interoperability Forum, Abernathy said the exchange and use of information looms large over her work as both principal deputy commissioner and acting chief information officer.

While working in the private sector, she said, she learned about the importance of FDA because regulations set the guideposts within which industry works. “By clarifying what to do, and what not to do, regulations kept us from getting distracted and focused our energy on that which would be most impactful,” she said. “What I learned was that FDA both set the direction and clarified how to get there, particularly for development of medical products like drugs and devices, including technology-based solutions like software as a medical device.”

Abernathy said that as principal deputy commissioner, she is focused on (1) getting the agency’s own technical house in order, (2) using examples and cases that show what it looks like when technology and interoperable data are put into play; and (3) updating how FDA interfaces with the technology community in a meaningful way.

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