Completeness Assessments (CAs): Status, KASA for CA, Common Issues & GDUFA Commitment Letter Stats

Submit proposed questions on this poster to [email protected] by March 19, 2021, and tune in for the subsequent panel discussion during the Drug Master File (DMF) and Drug Substance follow-up webinar on April 9, 2021. To review posters and register for the webinar, visit: https://www.fda.gov/drugs/news-events... This poster discusses CA statistics, application of KASA, and advice for improving the CA outcome. To view all posters and conference presentations, visit: https://www.fda.gov/drugs/news-events... To listen to a Q&A on poster and conference topics, visit: https://www.fda.gov/drugs/news-events... FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.     Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2021 Playlist -    • 2021 CDER Small Business and Industry Assi...   SBIA LinkedIn:   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - [email protected]   Phone - (301) 796-6707 I (866) 405-5367