Regulatory Focus™ > News Articles > Office of Generic Drugs Receives New Director

Office of Generic Drugs Receives New Director

Posted 16 July 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) announced 14 June the hiring of Greg Geba, MD, MPH as the new Director of the Office of Generic Drugs (OGD).

Geba is a 15-year veteran of industry, having served most recently as the Deputy Chief Medical Officer for Sanofi US. In an email sent to internal FDA staff, the Office of Pharmaceutical Science (OPS) said it was particularly pleased with Geba's track record of "more than 20 currently marketed drugs or devices across multiple therapeutic areas."

"In doing so, he successfully employed his working knowledge and demonstrated practical application of drug manufacturing processes, current quality and risk management processes, and standards relevant to FDA's laws and regulations," OPS wrote.

In taking the Director position, Geba will join the agency just as it is tasked with implementing the FDA Safety and Innovation Act, which will channel hundreds of millions of dollars in industry fees to OGD over the coming decade while instituting several review metrics for the Office to meet.

Geba will replace acting director Keith Webber, who has been tasked with running OGD since March 2010 when Director Gary Buehler transitioned to the Office of Pharmaceutical Science-the office that oversees OGD.

Read more:

The Pink Sheet - FDA Office Of Generic Drugs Director Has Brand Industry Background

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