An evaluation of the minutes of subject expert committee meetings of novel COVID-19 proposals.

Abstract

We analyzed minutes of the SEC meetings on COVID-19 (April 8, 2020–January 31, 2021) and excluded items that were postponed/deferred or were internal discussions. Each item was classified as initial/ repeat application; category of the interventional product was classified as repurposed/novel and the therapeutic area was noted down. The purpose of the application was classified as permission to conduct computed tomography [CT]/amendment of approved protocol/ Marketing authorization (MA) with CT waiver or MA post-CT].