USA – Policy for Certain REMS Requirements During the COVID19 Public Health Emergency : Guidance

The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the
United States 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 for certain risk evaluation and mitigation strategies (REMS) requirements for the duration of the public health emergency (PHE) declared by the Secretary of Health and Human Services (HHS) on January 31, 2020…