The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States (U.S.) from threats including 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.

FDA is issuing this guidance to communicate its temporary policy with respect to certain risk evaluation and mitigation strategies (REMS) requirements for tocilizumab due to the shortage related to the COVID-19 public health emergency (PHE). ,    This guidance will remain in effect for the duration of the tocilizumab shortage.  FDA is continually assessing the needs and circumstances related to this temporary policy.  As relevant needs and circumstances evolve, FDA intends to update, modify, or withdraw this policy as appropriate.

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