FDA Policy/General

Amazon Hires Former FDA Chief Information Officer

Amazon has hired former FDA chief health information officer Taha Kass-Hout, a sign that the online retailing behemoth may be challenging Google and its X Lab in the health technologies race, according to a CNBC report. Kass-Hout has been quietly brought on at Amazon to serve in a business development role focusing on health care projects, the report says. He will work alongside Amazon Grand Challenge chief Babak Parviz, a former director at Google X who joined Amazon in 2014 as a vice president. The Amazon group has also been referred to internally as 1492, and it reportedly has a huge focus on the health sector like Google X.

The CNBC report speculates that Kass-Hout may have been hired to spur Amazon’s move toward helping consumers get easier access to health records. Both Apple and Alphabet have launched initiatives on consumer access to personal medical information, which is currently scattered across various health systems, it says.

Kass-Hout most recently worked at Michigan’s Trinity Health, where he served as a senior vice president. In this capacity, he offered “leadership and oversight over data, analytics and digital health initiatives,” according to his online profile.

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