FDA Policy/General

FDA Digital Health Leader Leaves for Mayo Clinic

Former FDA Digital Health Center of Excellence acting director Sonja Fulmer has left the agency to accept a position at Mayo Clinic as senior director of health policy. Fulmer had been at the agency for 11 years, and assumed her role as acting director in April after director Troy Tazbaz, who served two years, returned to Oracle, where he previously served for more than 10 years as senior vice president for data center planning.

Advancing the use of digital health technologies (DHTs) is a priority for FDA. A recent JAMA Health Forum open-source article by three Digital Health Center of Excellence staffers recommended engaging early with FDA when planning to integrate DHTs into a clinical investigation to design a trial that will provide meaningful results. The article cites a recent FDA guidance on conducting clinical trials with decentralized elements and makes these points:

the agency anticipates that reducing the burden on trial participants will improve trial recruitment, participant engagement, and retention throughout the trial;
using DHTs in clinical investigations may facilitate the inclusion of certain participants with physical or cognitive disabilities or pediatric participants; and
FDA sees the potential for DHTs to capture novel measures that are used to support endpoints in medical product clinical 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