Nonclinical Safety in Small Molecule & Biologic Development

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.

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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.

Upcoming training and free continuing education credits: https://www.fda.gov/cdersbia

CDER SBIA 2018 Playlist: https://www.youtube.com/playlist?list=PLey4Qe-UxcxZvRWJ6dulyw1P5eQWWztz1
LinkedIn: https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance
Training resources: https://www.fda.gov/cderbsbialearn

Twitter: https://twitter.com/FDA_Drug_Info

CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionmanagement

Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367