New OGD Director Geba May Take the Helm of a Super Office; CDER Director Woodcock Sharpening Center’s Quality Focus

The new director of the Office of Generic Drugs (OGD) will likely take the helm of a new FDA “super office,” being proposed to reflect the heightened focus on generic drug regulation and the challenges posed by an increasing number of applications and the passage of the Generic Drug User Fee Amendments (GDUFA).

OPS announced the selection of Gregory Geba as Director of the Office of Generic Drugs (OGD) in mid-July.  In the proposed restructure, Geba would report directly to CDER Director Janet Woodcock rather than through the agency’s Office of Pharmaceutical Science (OPS).

Reflective of the proposal, Woodcock announced that “effectively immediately,” Geba will be detailed to her center director’s office.  Mary Beth Clarke, the acting director of the Office of Executive Programs, she said, will continue to be the CDER lead on GDUFA implementation.

Geba has served in senior-level clinical/managerial positions in the pharmaceutical industry for the past 15 years. He was most recently the Deputy Chief Medical Officer for Sanofi US, where he provided medical and scientific leadership and managerial direction to a staff of approximately 500 multidisciplinary scientific and regulatory professionals engaged in drug development activities across all therapeutic areas, as well as to the company’s field medical group.

[CLICK HERE for the complete story. and includes additional proposals Woodcock has made for sharpening CDER’s focus on quality.  Nonsubscribers can purchase the story for $195 by contacting Karen Bertani (karen@ipq.org).  For subscription/license information, click here.]