Petition updateApprove Cassava Sciences SimufilamEmergency Investigational New Drug (EIND) Application
Andrej AHallandale Beach, FL, United States
Feb 24, 2023

A physician may decide to request use of an investigational antiviral product through a single-patient Emergency Investigational New Drug (EIND) application if:

the physician considers the product may be urgently needed for the patient’s serious or life-threatening condition;
no satisfactory alternative therapy is available; and
the patient cannot receive the product through any existing clinical trials or expanded access protocols

 

https://www.fda.gov/drugs/investigational-new-drug-ind-application/emergency-investigational-new-drug-eind-applications-antiviral-products

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