Biologics

Vaccine EUA Would Follow Efficacy: Marks

CBER director Peter Marks told an online Disease Control and Prevention Summit that FDA could issue an emergency use authorization (EUA) for a Covid-19 vaccine in a matter of weeks once the vaccine’s efficacy requirements are met. CNN reports that Marks told the summit the increased attention FDA is paying to coronavirus vaccine trials should speed the process of granting an EUA to a vaccine that crosses an efficacy boundary in a clinical trial.

“We’d like to hope that when that happens, it will be a matter of weeks before we can actually potentially have something like an emergency use authorization,” Marks said, adding that he hoped an EUA would apply to a relatively broad population. “Emergency use authorization will be for the population for which we have appropriate data.”

Marks described the schedule as “aspirational timelines,” saying it’s good that people aspire to move forward as quickly as possible but “we all know that real life generally does not go as well as our aspirations.”

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