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Opening Up the Black Box: FDA Wants To Make "Complete Response" Letters Public

This article was originally published in RPM Report

Executive Summary

FDA's transparency initiative is starting to take shape. While many industry executives see the value in making more information available to the public, one idea makes them nervous: publicizing the letters FDA sends when it declines to approve a new drug or biologic. Top FDA officials already support making "complete response" letters public, and the Commissioner's office is open to the idea. How should industry prepare?

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