Biologics

FDA May Decline Covid-19 EUA Requests

FDA has updated its guidance on Emergency Use Authorization (EUA) for Vaccines to Prevent Covid-19 to include a new section that says the agency may decline to review and process further EUA requests other than those for vaccines whose developers have already engaged with the agency. “Additionally, given the need to address urgent public health priorities, FDA may need to further prioritize among the EUA requests it receives for Covid-19 vaccine candidates,” it says.

Presumably, the agency move is acknowledging that its limited resources have been stretched and should be focused on current and viable EUA candidates. “When FDA assesses investigational Covid-19 vaccines for use under EUA, FDA’s review includes: stringent evaluation of product quality, including a determination that the facilities producing the product meet appropriate standards; evaluation of the conduct of clinical trials; and assessment of trial data integrity,” the guidance says. “FDA intends to decline to review and process EUA requests in cases where it is not feasible for the agency to verify any one of these characteristics.”

FDA insists that early interaction with the agency is critical, and Covid-19 vaccine developers should have the benefit of FDA feedback early and throughout the development process. “Therefore, their EUA requests are more likely to contain the comprehensive data and information needed to demonstrate that issuance of an EUA is appropriate, and the agency is more likely to be able to confirm the validity of the clinical and manufacturing information submitted in the EUA request,” the guidance adds.

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