Submitting Copies of FDA Correspondence
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To help assure compliance with FDA regulations, sponsor-investigators will submit all documents relevant to the IND/IDE to a University documentation unit (a central file). These documents include the application, communications, safety reports, amendments, and annual reports.
Documents should be submitted
As they are received or sent.
Paper documents should be sent to this address:
IND/IDE Assistance Program
420 Delaware St. S.E.
(Room 507 Children's Rehabilitation Center)
Electronic documents should be sent to: