GUIDANCE DOCUMENT
Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals December 2021
- Docket Number:
- FDA-2020-D-1137
- Issued by:
-
Guidance Issuing OfficeCenter for Biologics Evaluation and Research
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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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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All written comments should be identified with this document's docket number: FDA-2020-D-1137.
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