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Straight Talk from FDA: Wyeth R&D Head Reacts to Climate Change for NDA/BLA Reviews

This article was originally published in RPM Report

Executive Summary

Wyeth has had some tough times with FDA on its current crop of NDAs.Those experiences sent a team of senior execs down to FDA to find out what is up at the agency. What the execs heard was a call to action. The meeting "caused us at Wyeth to realize that we have to find a different way to operate." The current series of delays and rejections for important new drug applications is not a temporary situation for companies to ride out, but rather a sign of new regulatory

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