A pair of guidance documents seek to streamline the process of submitting applications to initiate clinical studies and give recommendation for designing clinical trials.
The U.S. Food and Drug Administration (FDA) has produced two guidance documents aimed at accelerating the development of COVID-19 coronavirus prevention and treatment options, according to a news release.
The release says the FDA’s Coronavirus Treatment Acceleration Program has led to more than 130 ongoing clinical trials of potential COVID-19 related drugs and biologics being performed with FDA oversight.
The first guidance document outlines a new process for developers to receive feedback on their supporting data from the agency by clarifying the types of data and information they should provide to address clinical, nonclinical, and quality considerations before submitting their application to begin a study. The second guidance document outlines sponsor considerations like appropriate patient selection, and how to design a trial, the release says.
“Our staff continues to work around the clock with the world’s best innovators and researchers to help expedite the development of prevention and treatment options for COVID-19,” FDA Commissioner Stephen M. Hahn, MD, says in the release. “Accelerating the investigation of safe and effective therapies that could benefit people affected by the COVID-19 pandemic is one of the FDA’s highest priorities. We are committed to maximizing our regulatory flexibility and using every tool at our disposal to speed the development and availability of these medical products and believe these new guidances will help innovators and researchers do just that.”
The guidance documents are joined by supplemental ongoing activities and agency guidance. The FDA is currently engaged in a public-private partnership with the National Institutes of Health and others in an effort to speed the development of a vaccine and treatment options for COVID-19. The COVID-19 Therapeutic and Vaccines partnership includes European government partners and more than 12 biopharmaceutical companies and seeks to build a collaborative framework for prioritizing vaccine and drug candidates, streamlining clinical trials, coordinating regulatory processes, and leveraging assets among partners to rapidly respond to this and future pandemics, the release says.