All Times EDT
Keywords: COVID, EUA, Regulatory
Emergency User Authorization guidance from the FDA to get diagnostic tests, screening tests, and vaccines to the market during the pandemic allowed for quicker pathways to market due to the pandemic. One example for serology testing was that development stability studies, which can take months to complete, were not originally required for product dating; accelerated life testing was used for initial product dating with development stability studies continuing as a post-market study. Vaccines also reached the market in record-approval time. Treatments were also approved extremely quickly. 1) What were the different significant time-saving items for testing, treatment, and vaccines? 2) Can any of these time-saving measures be applied in future guidance of submissions? 3) Did Industry learn anything that could speed development or manufacturing? 4) Will any of these items be considered for future, non-pandemic development and approval?