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  • Request For CSP

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    Loreto District Hospital LDH
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    A physician wrote to the Officer-in-Charge of the Food and Drug Administration requesting a compassionate special permit to use remdesivir to treat severe COVID-19 patients at their institution. The physician requested a specific number of vials of remdesivir, which would be supplied by AJ Research & Pharma Inc. The physician acknowledged that the FDA would not be liable for any harm caused by the unregistered drug.

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    A physician wrote to the Officer-in-Charge of the Food and Drug Administration requesting a compassionate special permit to use remdesivir to treat severe COVID-19 patients at their institution. The physician requested a specific number of vials of remdesivir, which would be supplied by AJ Research & Pharma Inc. The physician acknowledged that the FDA would not be liable for any harm caused by the unregistered drug.

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    © All Rights Reserved
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    7 views1 page

    Request For CSP

    Uploaded by

    Loreto District Hospital LDH
    A physician wrote to the Officer-in-Charge of the Food and Drug Administration requesting a compassionate special permit to use remdesivir to treat severe COVID-19 patients at their institution. The physician requested a specific number of vials of remdesivir, which would be supplied by AJ Research & Pharma Inc. The physician acknowledged that the FDA would not be liable for any harm caused by the unregistered drug.

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    of 1

    September 22, 2020

    Dr. Rolando Enrique Domingo, DPBO


    Officer-in-Charge
    Food and Drug Administration
    Department of Health

    SUBJECT: APPLICATION FOR COMPASSIONATE SPECIAL PERMIT- REMDESIVIR

    Dear Dr. Domingo,

    As part of our efforts in managing patients with severe COVID-19 in our institution, we would
    like to request for the Compassionate Special Use of Remdesivir 100 mg Lyophilized
    Injection.

    We would initially be needing no. vials of Remdisivir and it will be supplied by AJ Research &
    Pharma Inc.

    We are aware that FDA is not liable for any damage or injury arising from the use of the
    unregistered drug.

    Trust this finds you well and we would highly appreciate your positive response on this.

    Thank you very much!

    Kind regards,

    NAME AND SIGNATURE OF PHYSICIAN


    NAME OF INSTITUTION

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