On The Docket: Recent Submissions For US FDA Approval
Round-up of late summer applications recently submitted to US FDA, adapted from the Pink Sheet FDA Performance Tracker's User Fee Goal Dates chart.
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Created last year under the Office of New Drugs reorganization, ONDP works to promote regulatory consistency while fostering innovation – and reacting to unexpected challenges like the pandemic.
US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.