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A Slow Takeoff for FDA's Brand Name Pilot Program

This article was originally published in RPM Report

Executive Summary

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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