Biologics

Sen. Johnson Wants Covid Interviews with Former FDAers, Fauci

Sen. Ron Johnson (R-WI), chairman of the Senate Permanent Subcommittee on Investigations, has requested that former CBER director Peter Marks, former CDER officials Narayan Nair, Steven Anderson, and Manette Niu, and former National Institute of Allergy and Infectious Diseases director Anthony Fauci appear for transcribed interviews about their roles in responding to the Covid-19 pandemic, including the safety and efficacy of Covid vaccines. Wispolitics reports that Johnson released on 4/29 an interim report purporting to show that some FDA senior officials “turned a blind eye toward warnings that their vaccine safety monitoring system was hiding safety signals for the Covid-19 vaccines.” The news service says that Marks, Nair, Anderson, and Niu were among the officials Johnson identified as ignoring the warning signals.

“I hope that you will be cooperative and fully transparent regarding your involvement and knowledge of these issues,” Johnson wrote to each of the officials.

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