FDA Issues New Guidance for Development of COVID-19 Drugs and Biological Products
On May 11, 2020, the U.S. Food and Drug Administration (“FDA”) issued new guidance on the development of drugs and biologics to treat or prevent COVID-19: COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products (“Pre-IND Guidance”) and COVID-19: Developing Drugs and Biological Products for Treatment or Prevention (“Clinical Development Guidance”) (collectively, “the Guidances”). These two Guidances follow other recent efforts by FDA, such as the launch of the Coronavirus Treatment Acceleration Program (“CTAP”), to support the development of potential COVID-19 therapies.
Taken together, the Guidances make clear that sponsors developing COVID-19 pharmaceutical products should develop plans to study the products in human clinical trials and to engage with FDA to obtain the Agency’s feedback on the development program, including trial design, study populations, efficacy endpoints, safety issues, and statistical considerations. These Guidances reflect FDA’s strong preference for randomized, double-blind, placebo-controlled trials, as opposed to the use of expanded access programs or premature requests for an emergency use authorization (“EUA”). Given the volume of COVID-19 submissions FDA has received, FDA strongly encourages sponsors to consider the Agency’s recommendations carefully as they build their drug development and regulatory strategies.
Denise Esposito, et al., FDA Issues New Guidance for Development of COVID-19 Drugs and Biological Products, Covington Alert (May 18, 2020), https://www.cov.com/en/news-and-insights/insights/2020/05/fda-issues-new-guidance-for-development-of-covid-19-drugs-and-biological-products
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Denise Esposito, Kristie Gurley & Allison M. Whelan,
FDA Issues New Guidance for Development of COVID-19 Drugs and Biological Products,
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