The overwhelming spread and growing impact of COVID-19 has resulted in the need for quick, solution-oriented action to address the threat this pandemic poses to public health. To this end, the US Food and Drug Administration (FDA) has prioritized efforts to expedite the development, approval, and emergency access to potential treatments. One new initiative is the implementation of the Coronavirus Treatment Acceleration Program (CTAP) created specifically to accelerate the availability of new treatments and vaccines to COVID-19 patients. Existing regulatory programs such as the Emergency Use Authorization (EUA) and Single Patient Expanded Access (Compassionate Use) pathways are also being used to expedite emergency access to potential promising treatments. Additionally, the FDA has issued numerous COVID-19 specific final guidances to help companies optimally navigate these regulatory pathways, seek meetings with the FDA, and expedite the development of COVID-19 treatments.
The availability of these multiple FDA pathways makes it difficult to identify which pathway is appropriate for specific assets and the timing of FDA interactions to seek approval/concurrence for the selected pathway. This webinar will provide a concise overview of these FDA initiatives and strategic regulatory guidance for selecting the optimal regulatory pathway for COVID-19 treatment development programs in the US.