FDA Policy/General

Former Officials Find New Roles After FDA

Former CDER associate director for genomics (2004-2008) Felix Frueh has joined NDA Partners as an expert consultant. At FDA, he led the agency’s first genetic and genomic review division and established the biomarker qualification process and companion diagnostic development policies. In his new role, Frueh will use his genetic and genomic product knowledge to assist clients developing precision medicine therapies, the consultant group says.

Previously, Frueh oversaw the creation of the next-generation, CLIA-certified, whole human genome sequencing laboratory as the chief scientific officer of human longevity, according to NDA Partners. He also served as president of Medco Research Institute, pharmacogenetics research director at Transgenomic, and assistant director of Protogene Laboratories.

Meanwhile, former FDA chief of staff Lauren Silvis, who left the agency in June following former commissioner Scott Gottlieb’s departure, has joined Tempus, a technology company advancing precision medicine through the collection and analysis of molecular and clinical data at scale. At Tempus, Silvis will serve as external affairs vice president and oversee regulatory, public policy and government affairs. She will operate from a new office in Washington, DC. At FDA, she previously served as CDRH deputy Center director for policy. And prior to FDA, Silvis was a partner at Sidley Austin in the firm’s food, drug, and medical device regulatory practice.

Tempus is building what it describes as the “world’s largest library of molecular and clinical data and an operating system to make that data accessible and useful, in an effort to bring the power of artificial intelligence to healthcare. We enable physicians to make real time, data-driven decisions and deliver personalized care for patients through our interactive analytical and machine learning platform.”

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