This presentation will explore the statutory 30-month stay of FDA approval in ANDA litigation as well as the 180-day exclusivity period that may be available to first filers of paragraph IV certifications.  The presentation will focus on the effect of the 2003 MMA on the FDA's decisions concerning 30-month stays and 180-day exclusivity periods.

Hatch Waxman and the FDA:  Effect of the 2003 Medicare Modernization act on the FDA's decisions concerning 30-month stays and 180-day exclusivities in ANDA litigation

243rd National Meeting (2012)

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