Getting Organized for GDUFA: FDA Elevates Generic Review Activities Under New Director Geba
This article was originally published in RPM Report
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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FDA’s proposed Office of Pharmaceutical Quality will be initially headed by CDER Director Janet Woodcock. OPQ would hold responsibility over the manufacturing quality of a drug or biologics throughout a product’s lifecycle; eight offices will oversee activities from policy development to surveillance.
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?
Mylan played a pivotal role in crafting the formula to create Generic Drug User Fees. The selection of Rep. Tim Murphy (R-Pa.) to chair the House Energy & Commerce Oversight Subcommittee should help assure that Mylan’s perspectives continue to play an important role.