Nucala Clinical Development Timeline
Chronicle of the development and review of GSK's mepolizumab.
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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.
The FDA emphasized the rigor of its review of the first COVID-19 therapy, which used few expedited pathways on its way to approval after a two-and-a-half-month review. Post-marketing studies will address remaining concerns about dosing and special populations.