US FDA’s New Acting Generics Chief Relearning System After 24 Years Of Experience

Acting OGD Director Susan Rosencrance says in an interview that the generics assessment system has evolved substantially since she moved to the Office of Pharmaceutical Quality in 2015.

Generic drugs
Susan Rosencrance has been acting OGD director for less than a month. • Source: Shutterstock

The new acting director of the US Food and Drug Administration’s Office of Generic Drugs, Susan Rosencrance, spent 24 years working there, but that experience is largely outdated after only a few years at the Office of Pharmaceutical Quality, a close partner in the ANDA assessment program.

Rosencrance, who had been director of the Office of Lifecycle Drug Products in OPQ, said OGD has changed substantially, thanks to the generic drug user fee program. Her early days...

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