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SUPPLEMENTAL PHYSICIAN REQUEST FORM FOR
CONVALESCENT PLASMA FOR COVID-19
Please complete all required information & return this form to your Transfusion Services/ Blood Bank
Hospital Name: ___
Patient
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How to fill out emergency use authorization request
How to fill out emergency use authorization request
01
Fill out the required forms provided by the regulatory authority.
02
Include all necessary information such as product details, intended use, supporting data, etc.
03
Submit the completed request to the regulatory authority for review.
Who needs emergency use authorization request?
01
Any manufacturer or sponsor seeking to gain authorization to use a product or device in emergency situations.
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What is emergency use authorization request?
Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic.
Who is required to file emergency use authorization request?
Manufacturers or sponsors of medical products seeking authorization for emergency use are required to file an EUA request with the relevant regulatory agency.
How to fill out emergency use authorization request?
To fill out an EUA request, manufacturers must provide data on safety and effectiveness of the product, proposed labeling, manufacturing information, and details on distribution plans.
What is the purpose of emergency use authorization request?
The purpose of an EUA request is to allow for the emergency use of medical products that have not been fully approved, providing access to treatments and vaccines during public health crises.
What information must be reported on emergency use authorization request?
Information reported on an EUA request includes clinical trial data, safety profiles, proposed labeling, manufacturing processes, and distribution plans.
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