FDA Is Still Lenient On COVID-19 EUAs, Veru’s Sabizabulin Advisory Panel Preview Docs Indicate
Agency poised to authorize Veru’s NME for COVID acute respiratory distress despite potential efficacy concerns and an unusually small safety database even by EUA standards. FDA assessment highlights continued burden of COVID despite political rhetoric downplaying current impact.
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In a close but negative panel vote on the company’s acute respiratory distress syndrome treatment VERU-111 (sabizabulin), majority of US FDA advisory committee says more study should come ahead of an emergency use authorization, not as an authorization condition.
President Biden’s informal declaration that the COVID-19 pandemic is ‘over’ likely portends a formal end of the Public Health Emergency. But many of the US FDA’s COVID flexibilities don’t directly depend on that decision.
Final guidance excludes stool banks, putting in place more limited enforcement discretion regarding the requirement of an investigational new drug application for use of fecal transplants to treat C. diff infections, likely paving way for shift to any FDA-approved product.