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CLINICAL STUDY PROTOCOL Amendment No. 3 Final Version Date: 14 May 2019 Amendment No. 2 Final Version Date: 05 October 2018 Amendment No. 1 Final Version Date: 02 February 2018 Original Protocol Final
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How to fill out emergency use authorization
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Obtain the necessary information and documentation for the emergency use authorization application.
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Complete the required forms and provide detailed information about the product or treatment being authorized.
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Manufacturers of medical products or treatments seeking authorization for emergency use in response to a public health crisis.
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Healthcare providers looking to use experimental or unapproved treatments in emergency situations where no other options are available.
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What is emergency use authorization?
Emergency use authorization is the process by which certain medical products can be used in an emergency situation before they are fully approved by regulatory agencies.
Who is required to file emergency use authorization?
Manufacturers or sponsors of medical products are required to file emergency use authorization.
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To fill out emergency use authorization, manufacturers or sponsors must provide relevant data and information about the product's safety and efficacy.
What is the purpose of emergency use authorization?
The purpose of emergency use authorization is to allow the use of medical products in emergency situations where traditional approval processes may take too long.
What information must be reported on emergency use authorization?
Information such as product safety data, clinical trial results, and proposed conditions of use must be reported on emergency use authorization.
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