FDA Policy/General

Update on FDA’s Technology Modernization Plan

Spurred by the Covid-19 emergency, FDA says it is speeding up the implementation of a software-defined network and adoption of other design approaches that make the transition to cloud-based technologies faster and more secure. This work is spearheaded by the agency’s Technology Modernization Action Plan (TMAP), which was launched one year ago to “support the rapidly increasing regulatory review workload and improve our overall digital and technological capabilities as an organization, an update from FDA principal deputy commissioner Amy Abernethy. Other current priorities FDA is implementing include:

Emphasis on user experience and the availability of modern technology capabilities that are useable from any device, including mobile devices.
Rapid deployment of modern team collaboration capabilities to enhance internal and external collaboration.
Adoption of agile methods and integrated security practices like “DevSecOps” that encourage sharing, reuse and agile delivery of IT solutions.

Part of FDA’s action plan is focused on living examples, or “use cases,” that showcase how data and technology are going to be used differently at the agency and bring the "possible” to life. “The FDA’s recently announced Import Screening Pilot for seafood unleashes the power of data and leverages artificial intelligence (AI) – priorities embodied in the TMAP,” Abernethy says. “AI technology could be a game changer in expanding the FDA’s predictive analytics capabilities, enabling the agency to mine data to anticipate and mitigate foodborne risks. The seafood pilot will explore incorporation of AI into real-time import operations enabling the FDA to clearly visualize how AI can be used to augment current technology to help us ensure the safety of imported foods.”

Additionally, Abernethy says FDA is partnering with Presidential Innovation Fellows to incorporate modern product development methods and technologies to improve the user experience of FDA’s workforce (consumer safety officers). “We are prototyping mobile optical character recognition to reduce data entry and increase efficacy of Consumer Safety Officers at points of inspection,” she says. “This need was discovered through research to understand how FDA staff and customers interacted with and experienced FDA’s technical products. This emerging user and customer experience focus will help ensure we’re tackling the right problem and creating the best solution.”

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