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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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Growing Pains for Generic Drugs: OGD Gains Respect, But Loses Geba

FDA’s Office of Generic Drugs was at the start of a turnaround: $299 million in new user fees to clear a big ANDA backlog and fund overseas inspections, an elevated status within the Center for Drugs and a brand-new director to steer the ship. But there have been some bumps in GDUFA implementation, and OGD’s new director, Gregory Geba, has abruptly left the agency. What next for FDA’s generic drug oversight?

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