Overview of Non-clinical Assessment in Drug Development (8/14) REdI 2017

Hanan Ghantous covers the role and responsibilities of the pharmacology/toxicology reviewer related to the various components of the Investigational New Drug (IND) phase of drug development. This presentation covers both scientific and regulatory pharmacology/toxicology concepts that are part of the non-clinical submission to an IND/ NDA/BLA. Viewers will gain an understanding of animal studies submitted to support the safety of clinical studies and marketing applications.
-------------------------
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: www.fda.gov/cdersbia
CDER SBIA 2017 Playlist: • 2017 CDER Small Busine...
LinkedIn: / cder-small-business-an...
Training resources: www.fda.gov/cderbsbialearn
Twitter: / fda_drug_info
CDER small business e-mail update subscription: updates.fda.gov/subscriptionm...
Email: [e-mail]
Phone: [phone] I [phone]