Get the free Subject: Approval of emergency rules (CR 103E) amending WAC 314-55-077
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Date:April 28, 2021To:David Postman, Board Chair Ollie Garrett, Board Member Russ Huge, Board MemberFrom:Kathy Hoffman, Policy and Rules ManagerCopy:Rick Garza, Agency Director Chandra Brady, Director
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What is subject approval of emergency?
Subject approval of emergency is the designation granted by regulatory authorities to allow the use of an investigational drug or device in emergency situations.
Who is required to file subject approval of emergency?
The principal investigator or sponsor of a clinical trial is required to file subject approval of emergency.
How to fill out subject approval of emergency?
Subject approval of emergency can be filled out by submitting the necessary forms and documentation to the regulatory authorities.
What is the purpose of subject approval of emergency?
The purpose of subject approval of emergency is to ensure that patients in emergency situations have access to potentially life-saving treatments.
What information must be reported on subject approval of emergency?
Subject approval of emergency must include information on the investigational drug or device, the emergency situation, and the justification for using the product.
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