FDA Takes New Actions to Accelerate Development of Novel Prevention and Treatment Options for COVID-19

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/covid-19-public-health-emergency-general-considerations-pre-ind-meeting-requests-covid-19-related?utm_campaign=FDA%20Takes%20New%20Actions%20to%20Accelerate%20Development%20of%20Novel%20Prevention%20and%20Treatment&utm_medium=email&utm_source=Eloqua

FDA Takes New Actions to Accelerate Development of Novel Prevention and Treatment Options for COVID-19

The U.S. Food and Drug Administration took important actions to help accelerate the development of prevention and treatment options for COVID-19 by providing new guidance with recommendations for innovators and researchers conducting work in this area. These guidance documents aim to make the process for submitting applications to initiate studies for new drugs and biological products more efficient and outline recommendations for ways to design clinical trials to evaluate safety and effectiveness of these medical products for COVID-19. 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. The FDA is committed to helping sponsors get potentially effective products into study quickly, while protecting the safety of patients. To that end, the guidance provides sponsors clarity on 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 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. The FDA anticipates this guidance will help sponsors to efficiently design studies that may lead to the review and potential approval of safe and effective drugs and biological products to address the COVID-19 pandemic.

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