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Components of New Drug Application and Biologics License Application (5of15) REdI- May 29-30, 2019 

U.S. Food and Drug Administration
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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 www.fda.gov/dr...
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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: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367
LinkedIn: / cder-small-business-an...
Twitter: / fda_drug_info
CDER small business e-mail update subscription: updates.fda.go...

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4 окт 2024

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