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 www.fda.gov/dr...
--_______________________________
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Visit www.fda.gov/cd... and www.fda.gov/cd... for news and a repository of training activities.
Email: [e-mail]
Phone: [phone] I [phone]
LinkedIn: / cder-small-business-an...
Twitter: / fda_drug_info
CDER small business e-mail update subscription: updates.fda.go...