The COVID Boom: CBER Receives More INDs in One Quarter Than The Previous 30 Combined
Bubble was short-lived, but still could create workload problems for the US FDA as it navigates the end of the coronavirus pandemic.
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The US FDA, HHS and White House, as well as industry groups, now must sign off on the document.
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.
Pre-IND inquiries are slowing and the FDA says more late-stage development work is coming.