COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention; Guidance for Industry; Availability
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention." FDA is issuing this guidance to assist sponsors developing master protocols for trials evaluating drugs and biological products for the treatment or prevention of COVID-19. This guidance primarily focuses on the trial design and conduct as well as statistical considerations for master protocols intended to generate substantial evidence of effectiveness and adequate characterization of safety for COVID-19. Additionally, this guidance provides administrative and procedural recommendations to sponsors of master protocols for COVID-19. Given the public health emergency presented by COVID-19, this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices.
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