Docket Number:
FDA-2020-D-1137
Issued by:
Guidance Issuing Office
Center 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))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1137.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010