FDA generics division officer joins Teva

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FDA generics division officer joins Teva

Home/Pharma News | Posted 03/12/2010 0 Post your comment

Teva Pharmaceutical Industries has added to its team Mr Gary Buehler, former head of the generics division at the FDA, The Wall Street Journal reported. Mr Buehler joins Teva as vice president of regulatory strategic operations.

Mr Gary Buehler, who for many years ran the FDA’s Office of Generic Drugs, has been persuaded to cross the line between government and industry and join Teva, the generics manufacturer.

The move comes just a few months after Mr Buehler, was reassigned to run the FDA’s Office of Pharmaceutical Science in March 2010. Mr Buehler, a 40-year government employee spent 24 years at the FDA.

Mr Buehler told The Wall Street Journal that he is “curious about how the other side operates” and that he is looking forward to learning the ins and outs of the generic industry and seeing where his experience with FDA can help the process.

There is plenty of work for Mr Buehler, with the backlog of generic drug approvals increasing from 891 in 2005 to 1,912 in 2010 and the process now taking an average of two years. Then there are the new biosimilar guidelines and of course generic user fees.

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Source: The Wall Street Journal. Teva Hires Former Senior FDA Official. 16 October 2010.