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LEGISLATIVE ANALYSIS AND PUBLIC POLICY ASSOCIATIONMODEL EXPANDED ACCESS TO EMERGENCY OPIOID ANTAGONISTS ACT SEPTEMBER 2021This project was supported by Grant No. G1999ONDCP03A awarded by the Office
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Model expanded access is for providing investigational drugs, biologics, or medical devices to patients outside of a clinical trial.
Who is required to file model expanded access to?
The sponsor or manufacturer of the investigational product is required to file model expanded access.
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Model expanded access forms can be filled out online through the FDA's Expanded Access Navigator.
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The purpose of model expanded access is to provide access to investigational products for patients who have exhausted other treatment options.
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Information such as patient demographics, medical history, reason for seeking access, and physician details must be reported on model expanded access forms.
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