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Industry Should Prefer Early Collaboration "Agreement" Meetings - Alpert

This article was originally published in The Gray Sheet

Executive Summary

FDA's propensity to suggest that sponsors hold non-binding "agreement" meetings in lieu of binding "determination" meetings in their pursuit of agency go-ahead is in industry's best interest, Susan Alpert, director of the Center for Devices and Radiological Health's Office of Device Evaluation, maintained.

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