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

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-... _______________________________ 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 https://www.fda.gov/cdersbia and https://www.fda.gov/cdersbialearn 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-and-industry-assistance   Twitter:   / fda_drug_info   CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm...