Keynote Address by Dr. Uhl (1of27) Generic Drugs Forum 2018

CDER Office of Generic Drugs Director Dr. Kathleen Uhl presents an update on FDA’s Generic Drug Program to include a summary of the successes of the Generic Drug User Fee Amendments (GDUFA) program and to spotlight the coordinated efforts of multiple CDER and FDA offices in the review of generic drug applications or ANDAs. She provides a high-level overview of the current GDUFA II program. Dr. Uhl highlights the positive impact of the GDUFA regulatory science program on generic drug product development, including complex generic drugs. 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. Upcoming training and free continuing education credits: https://www.fda.gov/cdersbia CDER SBIA 2018 Playlist:    • 2018 CDER Small Business and Industry Assi...   LinkedIn:   / cder-small-business-and-industry-assistance   Training resources: https://www.fda.gov/cderbsbialearn Twitter:   / fda_drug_info   CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm... Email: [email protected] Phone: (301) 796-6707 I (866) 405-5367