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PRE-SUBMISSION MEETINGS BETWEEN FDA AND SPONSOR NEED NARROW FOCUS GIVEN DIFFICULTIES INHERENT IN DEVELOPING BINDING AGREEMENTS, BURLINGTON TELLS FDLI

This article was originally published in The Gray Sheet

Executive Summary

Pre-submission meetings between FDA and the sponsor of a premarket approval application or investigational device exemption will require a narrow focus in order to produce a written agreement between the two parties, Center for Devices and Radiological Health Director Bruce Burlington said Dec. 10 at a Food & Drug Law Institute meeting in Washington, D.C. During pre-PMA and pre-IDE meetings, Burlington cautioned, "it's going to be important that we focus on those issues on which agreement is going to be negotiated."
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