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Posted On: 04/22/2020 7:02:15 PM
Post# of 149265
FDA eIND that physicians are using for Leronlimab until approval
Emergency Requests:
In an emergency situation, the request to use an unapproved investigational drug may be made via telephone or other rapid means of communication, and authorization to ship and use the drug may be given by the FDA official over the telephone. In these situations, known as emergency IND (eIND) requests, shipment of and treatment with the drug may begin prior to FDA’s receipt of the written IND submission that is to follow the initial request . An emergency IND timeline is available online to guide you through the process.
https://www.fda.gov/drugs/investigational-new...d-timeline
Emergency Requests:
In an emergency situation, the request to use an unapproved investigational drug may be made via telephone or other rapid means of communication, and authorization to ship and use the drug may be given by the FDA official over the telephone. In these situations, known as emergency IND (eIND) requests, shipment of and treatment with the drug may begin prior to FDA’s receipt of the written IND submission that is to follow the initial request . An emergency IND timeline is available online to guide you through the process.
https://www.fda.gov/drugs/investigational-new...d-timeline
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