FDA Policy/General

Gottlieb Vote on FDA Nomination Postponed to 4/27

The Senate Health, Education, Labor & Pensions (HELP) Committee has postponed a vote (see earlier story) until 4/27 on Scott Gottlieb to be the next FDA commissioner. The previous voted was scheduled for 4/26, but committee chairman Lamar Alexander (R-TN) postponed it due to a scheduling issue and a last minute request related to Gottlieb’s financial disclosure.

Earlier this month, the HELP Committee held a hearing where Gottlieb was grilled about his ties to industry (see earlier story). Gottlieb told members that his work with industry and investing in medical technology projects have taught him “the need for an absolutely objective regulatory watchdog over this field. If confirmed, I’ll lead the FDA as an impartial and passionate advocate for public health.”

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