FDA Policy/General

Former FDA Digital Health Guru Joins Big Health

Former FDA deputy commissioner for medical and scientific affairs Anand Shah has joined Big Health’s board of directors. Shah is being asked to help expand access to digital therapeutics as non-drug alternatives for mental health care, the company says, adding that he will take an active role in supporting its clinical and public policy strategies.

Shah held multiple senior leadership roles at FDA and the Centers for Medicare & Medicaid Services from 2016 to 2021, where he focused on bringing new technologies to market, redesigning health care delivery and payment models, and expanding consumer choice. At FDA, he developed multiple public health policies and programs including those related to digital health, clinical trials, and real-world evidence. At CMS, he led the clinical design of novel value-based payment and service delivery models, including those for advanced primary care, specialty care, and prescription drugs.

Big Health says its mission is to help millions back to good mental health by providing safe and effective non-drug alternatives for the most common mental health conditions including insomnia and anxiety. Designed by leading clinical experts, Big Health says its digital therapeutics are backed by industry-leading research and randomized controlled 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