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ADMINISTRATIVE PROCEDURE

Submitting Copies of FDA Correspondence

Printed on: . Please go to http://policy.umn.edu for the most current version of the Policy or related document.

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
MMC 406
420 Delaware St. S.E.
(Room 507 Children's Rehabilitation Center)

Electronic documents should be sent to:
ind@umn.edu

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Last modified on May 28, 2009