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FDA Brand Name Rejections: Avoiding the "Train Wreck" Scenario

This article was originally published in RPM Report

Executive Summary

It's become all too common for sponsors: out-of-the-blue rejections of preferred brand names because a competitor's product sneaks through at the last minute. Now the agency is considering a policy change that would make the process more predictable.

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A Slow Takeoff for FDA's Brand Name Pilot Program

FDA's pilot program for testing and approving proposed brand names is slowly beginning to gain traction-despite initial concern from drug sponsors that the new process would lead to longer review times. For early adopters, it means a chance to collaborate with FDA on what will likely become the new regulatory standard. For everyone else, it may mean being a step behind.

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