FDA releases Covid-19 guidance documents

The Food and Drug Administration (FDA) has released guidance documents for the development of prevention and treatment options for Covid-19.

The new guidance attempts to help the FDA streamline its review and advice process to ensure studies are able to begin as quickly as possible and provide information to individual innovators or researchers as soon as they can.

The first guidance is titled, “Covid-19 Public Health Emergency: General Considerations for Pre-Investigational New Drug application (IND) Meeting Requests for Covid-19 Related Drugs and Biological Products”. This outlines an efficient process for developers to receive agency feedback on their supporting data so organisations can begin clinical trials as soon as possible. As the FDA is committed to helping sponsors research potentially effective products quickly, whilst also protecting the safety of patients, the guidance 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 is titled, “Covid-19: Developing Drugs and Biological Products for Treatment or Prevention”. This guidance states the FDA’s current recommendations on later stage clinical trials which are focused on looking at the safety and effectiveness for Covid-19 products. The guidance outlines critical sponsor considerations e.g. appropriate patient selection. It also aims to help sponsors understand how to design their trials.

FDA Commissioner, Stephen M. Hahn, commented: “Our staff continue 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.

“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 maximising 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.”