CDER FDA Exclusivity – Which One Is for Me? - June 10, 2019

Rinku Patel from CDER’s Office of Generic Drug Policy discusses considerations CDER uses to make exclusivity
determinations, the CDER exclusivity board, a case study on Crestor (rosuvastatin calcium tablets), a broad overview of FDA exclusivities and how they work, strategies to maximize the benefits of exclusivity in the current landscape, and resources and references.

Find more information at https://www.fda.gov/drugs/cder-small-...


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