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Getting Organized for GDUFA: FDA Elevates Generic Review Activities Under New Director Geba

This article was originally published in RPM Report

Executive Summary

In the two months since the enactment of the Generic Drug User Fee Act, FDA has announced a major recruitment from the brand sector to head its generic drug activities (Gregory Geba), approved one controversial transdermal generic (Watson’s lidocaine topical patch), and elevated the generic review activities to “Super Office” status.


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