FDA Policy/General

Trump to Name Stephen Hahn FDA Commissioner: BioCentury

President Donald Trump reportedly will nominate University of Texas MD Anderson Cancer Center chief medical executive Stephen Hahn to be FDA commissioner. BioCentury says sources familiar with the decision informed it of the choice. The nomination reportedly would be announced following completion of FBI background checks.

Hahn is said to be the top choice of HHS secretary Alex Azar. BioCentury says the most contentious issue facing Hahn in the confirmation process is likely to be the agency’s policies on vaping.

Trump must name a permanent commissioner, or new acting commissioner, by November 1, under terms of the Federal Vacancies Reform Act. BioCentury reports that acting commissioner Ned Sharpless is expected to remain in place during the confirmation process. He had been considered one of three primary candidates to be named commissioner, and letters supporting him had gone to Trump and Azar. It is assumed that he would return to his position as director of the National Cancer Institute upon leaving FDA.

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