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Former Sanofi exec Gregory Geba to head FDA’s office of generic drugs

Will lead introduction of generic drug user fee act

The US Food and Drug Administration (FDA) has appointed Sanofi's deputy chief medical officer Gregory Geba as director of its office of generic drugs.

Geba, whose industry experience is primarily in branded medicines, joins at a crucial time for generic drugs in the US, with the FDA extending its drug user fee system to cover generic and biosimilar products.

Previously, the user fee act, under which companies pay a cost to cover the regulatory process and ensure an efficient service, only covered prescription drugs.

Geba, who has 15 years serving in senior positions within the pharma industry, replaces acting director Keith Webber to oversee regulation of generic medicines.

During his time in the industry Geba contributed to the registration of more than 20 currently marketed drugs or devices across multiple therapeutic areas ensuring, the FDA said, a working knowledge of the its laws and regulations.

Geba, who had been at Sanofi since October 2010 where he managed a staff of about 500 scientific and regulatory professionals, also has experience in clinical research, filing new drug applications, biologic license applications and comparator studies.

Prior to his time at the French firm, he held senior positions at several other pharma companies, including as senior VP and global head, clinical development at MedImmune/AstraZeneca and VP, global head of respiratory, dermatology and infectious disease at Novartis. He also spent time at Merck & Co as senior director, clinical area head.

19th July 2012

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