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Institutional Review Board Human Research Protection Program 1 Park Avenue 6th Floor New York, NY 10016 http://irb.med.nyu.edu Expanded Access of IND/IDE CONSENT FORMPhysician Name: Department: Phone:
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Expanded access of indide allows patients to access investigational drugs outside of a clinical trial.
Healthcare providers are required to file for expanded access of indide on behalf of their patients.
Healthcare providers can fill out expanded access of indide by submitting the necessary forms and documentation to the FDA.
The purpose of expanded access of indide is to provide patients with serious or life-threatening conditions access to investigational drugs.
Information such as patient eligibility, drug information, dosing, and monitoring must be reported on expanded access of indide.
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