Policy for certain REMS requirements during the COVID-19 public health emergency: guidance for industry and health care professionals

Policy for certain REMS requirements during the COVID-19 public health emergency: guidance for industry and health care professionals

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
Language(s):
English
Format:
Text
Subject(s):
Coronavirus Infections -- epidemiology
Pandemics
Risk Evaluation and Mitigation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
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)1 on January 31, 2020. Given this PHE, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency's good guidance practices.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (7 pages)).
NLM Unique ID:
101772699 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/101772699