Last week, I gave a talk about non-patent exclusivity at ACI's FDA Boot Camp conference in Boston. The talk covered new chemical entity (5-year) exclusivity; new clinical trial (3-year) exclusivity; orphan drug exclusivity; pediatric exclusivity; and generic drug (180-day) exclusivity. You can download a copy of my slides here.
In June, I gave a talk about forfeiture of 180-day exclusivity at IIR's Generic Drugs Summit conference in Washington. The talk included a discussion of the "failure to market" forfeiture provisions, particularly the FDA's Acarbose and Granisetron decisions. You can download a copy of those slides here.
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