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Nonclinical Safety Assessment for Small Molecules and Biologic Drug Development (6of14) REdI 2018

CDER’s Hanan Ghantous discusses PINDs, INDs and NDAs/BLAs, and the FDA’s roles and responsibilities related to nonclinical safety assessment (pharmacology/toxicology) in detail. He provides case studies and a comparison of the development of biologic drugs vs. small molecule drugs will be presented. _______________________________ 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...   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