FDA Issues New Guidance to Accelerate Development of Prevention and Treatment Options for COVID-19

The guidances issued today build on steps taken by the FDA to streamline its review and advice process to get studies started as quickly as possible, and they incorporate information provided to individual innovators or researchers over the past several months.

The first guidance, “COVID-19 Public Health Emergency: General Considerations for Pre-IND (Investigational New Drug application) Meeting Requests for COVID-19 Related Drugs and Biological Products,” outlines a more efficient process for developers to receive agency feedback on their supporting data with the goal of starting clinical trials as soon as possible. It provides sponsors clarity on the types of data and information they should provide to address clinical, non-clinical 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 on later stage clinical trials intended to establish safety and effectiveness for COVID-19 products. The guidance outlines critical sponsor considerations such as appropriate patient selection, including the evaluation of therapies in patients at high risk of complications from COVID-19 (e.g., the elderly). In addition, the guidance helps sponsors to understand how to design their trials, including considerations of study duration, assessment of efficacy and monitoring for safety.

These guidance documents are supplemented by a variety of ongoing activities and broad agency guidance to support innovative study designs, including master protocols, to test multiple products and multiple populations simultaneously and get answers on safety and efficacy as quickly as possible.

“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,” said FDA Commissioner Stephen M. Hahn, M.D. “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.”