Components of New Drug Application and Biologics License Application (5of15) REdI– May 29-30, 2019
Автор: U.S. Food and Drug Administration
Загружено: 2020-03-27
Просмотров: 14045
Swati Patwardhan from CDER’s Office of New Drugs discusses review application approval pathways. She covers content and format of an application, review forms, and documentation with examples on best practices related to module I.
Learn more at https://www.fda.gov/drugs/cder-small-...
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