NDA and BLA Application Review Process (6of15) REdI Annual Conference - May 29-30, 2019 

Lois Almoza from CDER’s Office of New Drugs discusses the application review process. She covers the timeline for an application, end of review actions and their implications, and best practices to make an application as complete as possible.
Learn more at www.fda.gov/drugs/cder-small-...
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