US FDA’s Coronavirus Workload Shifting Beyond Idea Stage
Pre-IND inquiries are slowing and the FDA says more late-stage development work is coming.
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In FY '21 third quarter, on-time decision rate improved for generics and biosimilars, but dropped again for new drug applications.
Bubble was short-lived, but still could create workload problems for the US FDA as it navigates the end of the coronavirus pandemic.
Acting CDER Director Cavazzoni says it is ‘a very active time’ as many clinical trials for COVID-19-related products are expected to read out soon.