19 March 2020

Guidance for Industry, Investigators, and Institutional Review Boards

"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 continuity and
response efforts to this pandemic.

FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the
safety of trial participants, maintaining compliance with good clinical practice (GCP), and
minimizing risks to trial integrity during the COVID-19 pandemic.

Given this public health emergency, 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.

In general, FDA’s guidance documents, including this guidance, do not establish legally
enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic
and should be viewed only as recommendations, unless specific regulatory or statutory
requirements are cited. The use of the word should in Agency guidance means that something is
suggested or recommended, but not required."

DOWNLOAD THE FINAL GUIDANCE DOCUMENT

Image