ABSTRACT

FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic: Guidance for Industry, Investigators, and Institutional Review Boards [Updated on April 16, 2020]   [open pdf - 236KB]

From the Introduction: "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. [...] This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service (PHS) Act."

Publisher:
Date:
2020-04-16
Series:
Copyright:
Public Domain
Retrieved From:
U.S. Food and Drug Administration: https://www.fda.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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