FDA further streamlines COVID-19 treatment studies

The Food and Drug Administration (FDA) released a document this week to help accelerate the development of prevention and treatment options for COVID-19. The guidance aims to make the process for submitting applications to initiate studies for new drugs and biological products more efficient. It also outlines recommendations for ways to design clinical trials to evaluate the safety and effectiveness of these products for COVID-19. More than 130 clinical trials of potential COVID-19-related drugs and biological products are underway with FDA oversight, and additional development programs for other agents are in the planning stages. (FDA news release, 5/11/20)