May 12, 2020 -- With over 140 clinical trials of potential COVID-19-related drugs and biological products underway, the U.S. Food and Drug Administration (FDA) issued new guidance to streamline its therapy revision process.
Shortly after COVID-19 emerged as a global pandemic, the agency launched the Coronavirus Treatment Acceleration Program (CTAP) to move medical products to the clinic as quickly as possible, while at the same time finding out whether they are helpful or harmful.
Given the urgent nature of the pandemic and the number of companies and researchers developing COVID-19-related therapies, the agency issued two new sets of guidelines on May 11.
The first guidance, "COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products," outlines a more efficient process for developers to receive feedback on their data. The guidance also provides clarity regarding the types of data and information they should provide to address clinical, nonclinical, and quality considerations before submitting an application to initiate studies.
The second guidance, "COVID-19: Developing Drugs and Biological Products for Treatment or Prevention," provides the FDA's current recommendations for establishing safety and effectiveness of COVID-19 drugs in late-stage clinical trials. The guidance covers sponsor considerations such as patient selection and helps developers understand how to design their trials.
The directives are supported by ongoing, broad agency support for study design including master protocols and testing multiple products in multiple populations simultaneously. The agency is also engaged in the public-private partnership with the U.S. National Institutes of Health, called the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program to accelerate the development of COVID-19 vaccines and treatments.