Drugs

CDRH’s Sara Brenner Elevated to Acting Commissioner

CDRH associate director for medical affairs and chief medical officer for in vitro diagnostics Sara Brenner has been elevated to FDA acting commissioner under the Trump Administration. She previously served in the first Trump administration’s White House Office of Science and Technology Policy as a senior policy advisor for health and biomedical innovation.

Brenner joined CDRH 9/2019 and began concurrently serving (5/2020) as HHS diagnostic data lead as part of the U.S. Covid-19 response operations. In this capacity, she focused on data quality, harmonization, reporting, diagnostic device performance, and emerging technologies for public health, medical, and policy decision-making during the pandemic, according to her bio.

Brenner received her medical degree from the University of Iowa Carver College of Medicine. She also has a masters degree in health policy and administration from the SUNY Albany School of Public Health, and an undergraduate degree in genetics from Iowa State University.

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