Drugs

FDA Preparing for Combined Flu/Covid-19 Tests This Fall

FDA is evaluating several different tests that can simultaneously test for both the flu and Covid-19 as part of the preparation for fall and winter when the U.S. will likely face both, FDA commissioner Stephen Hahn told Fox Business 7/22. He said the combination tests will help “if someone goes in to see their doctor and it’s flu season there can be made a determination about whether it’s flu or Covid-19.” He warned that the U.S. needs to be working now to have in place everything needed to respond to flu plus Covid.

Hahn said FDA is working “very closely” with the CDC and flu vaccine manufacturers to make sure there is enough flu vaccine available.“So again, follow the CDC guidelines with respect to the flu vaccine — we definitely want more people to vaccinate against flu,” he said. The agency is also working with manufacturers to make sure there is an adequate supply of therapeutics used to reduce the severity of the flu, he added.

Meanwhile, Hahn said that Covid-19 has doubled the agency’s normal workload. Speaking at 7/22 Webinar hosted by the Paley Center for Media, Hahn said FDA is overseeing 140 Covid-related clinical trials and there are more than 450 Covid applications in the pipeline, according to a CNN report.

Hahn said the pace is not sustainable, but he’s committed to removing barriers to new drug approvals and to speeding up the process. “One way the FDA has been able to speed up the process is by prioritizing the applications that were submitted based on the merit of the science involved,” CNN reports. “The FDA used groups of agency scientists, doctors, nurses, pharmacists and others to go through applications and determine what the priorities should be.” The approval process was also expedited using rolling reviews to review data in real time. When clinical trials and an application for a new therapeutic or drug for Covid-19 patients is complete, then FDA can make a decision about the safety and efficacy of that product within days, and in some cases, within 24 hours of getting the final data set, he said.

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