FDA COVID-19 Developing Drugs and Biological Products for Treatment or Prevention

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COVID-19: Developing Drugs and Biological Products for Treatment or Prevention 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page I. INTRODUCTION FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. 2

FDA is issuing this guidance to assist sponsors in the clinical development of drugs for the 3 4

treatment or prevention of COVID-19. Preventative vaccines and convalescent plasma are not within the scope of this guidance. This guidance is intended to remain in effect for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), 1

This guidance has been prepared by the Office of New Drugs and the Office of Biostatistics in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. 2

For the purposes of this guidance, all references to drugs include both human drugs and biological products unless otherwise specified. 3

Clinical trials of preventative vaccines raise different and additional considerations, including those pertaining to subject selection, safety monitoring, and effectiveness evaluation. We encourage developers of preventative vaccines to contact the Office of Vaccines Research and Review in CBER and to see the guidances Emergency Use Authorization for Vaccines to Prevent COVID-19 (February 2021) and Development and Licensure of Vaccines to Prevent COVID-19 (June 2020). We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-

guidance-documents. 4

FDA has issued guidance to provide recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigational-covid-19-convalescent-

plasma.

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