Revance Therapeutics Inc (RVNC)

[mouton29]

The article is reporting on this GAO report. https://www.gao.gov/products/gao-21-409t

I haven't studied it carefully, but this paragraph is of some interest:

The need to conduct preapproval inspections represents another challenge for FDA. As of November 2020, FDA officials told us that the agency had not experienced a significant effect on approval decisions due to the COVID-19 inspection pause. FDA notes that it is continuing its work to review and approve drug applications and that, as of October 2020, the agency had approved more than 600 brand name and generic drug applications in 2020. Representatives from three associations representing drug manufacturers stated that, because preapproval inspections may happen months before an application is approved, the postponement of inspections has not had a significant effect on FDA’s ability to make drug approval decisions yet. However, two of these associations noted that the longer inspections are postponed, the more
likely the inability to conduct a preapproval inspection could create larger challenges for FDA’s ability to make approval decisions. FDA officials said that they are expanding the use of alternative tools to mitigate the effect of the pandemic on the agency’s ability to make approval decisions when inspections are not possible.