Geba Gone

  • by: |
  • 03/14/2013
Changes in CDER's Office of Generic Drugs

CDER Staff:

I would like to make you aware of a change in the Office of Generic Drugs’ (OGD) leadership.

Dr. Greg Geba, OGD director, has informed me that he will resign from his position on March 15. With the pending realignment of OGD’s CMC functions into the new Office of Pharmaceutical Quality (OPQ), which Dr. Geba fully supports as part of the quality evolution in CDER, he nonetheless saw this movement as creating challenges for implementing his original and full vision for OGD’s remit. Additionally, it put into new perspective considerations for him relocating his family to the Washington, D.C. area.

Dr. Geba came to CDER during a busy time and has led OGD’s work to improve efficiencies in the generic drug review process — significantly reducing the backlog of pending ANDAs, preparing for the hiring of new staff, and successfully guiding OGD in implementing the Generic Drug User Fee Act (GDUFA), as well as overseeing OGD-related organizational changes to stand up the new OPQ.

Please join me in thanking Dr. Geba for his significant contributions and wishing him well.

In the interim, I will serve as the acting OGD director while we initiate a nationwide search for our next OGD director.

Janet Woodcock
CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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