US FDA's Submission And Review Estimates For 2020
US FDA's FY 2020 budget request include estimates of new, generic and OTC drug reviews and approvals, although some estimates may not represent the agency's expectations.
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US FDA provides a few hints about upcoming industry application filing volume and the agency's assessment pace in FY 2020 budget documents.
User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.
First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.