FDA Policy/General

ODT Launches Leadership Modernization Action Plan

The FDA Office of Digital Transformation (ODT) has launched a technology-focused Leadership Modernization Action Plan (LMAP), the next step in its enterprise transformation efforts. FDA chief information officer Vin Desai and executive officer Jessica Berrellez write in an FDA Voices online post that the LMAP is “the final piece of the agency’s technology modernization frameworks that are in action today and place people, and technology leaders, at the forefront of these efforts.”

They say the three elements of the LMAP are to:

create an environment where business and IT programs are aligned and collaborate to achieve business priorities and leverage IT opportunities to enhance outcomes;
develop and operationalize an IT strategy that reflects business needs; and
develop a pipeline of new technology leaders who can maintain strategic continuity through leadership and organizational change.

“Through modernization,” Desai and Berrellez write, “we aim to cultivate FDA’s technology leadership ability to support our digital transformation goals. ODT’s increased focus on people, leadership, and organizational culture in the context of modernization efforts will foster an environment that attracts and retains top talent. We will also work to cultivate technology leaders and change agents at every level of the organization. ODT will start with small pilots to test innovative technology talent and leadership development strategies. The LMAP highlights current or upcoming pilots focused on technology change leadership training, technology workforce upskilling, and enhancing ODT’s hiring and compensation strategy.”

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