Stability Case Studies (20of28) Generic Drugs Forum - Apr. 3-4, 2019

CDER Office of Pharmaceutical Quality’s Nusrat (Nusie) Motlekar and Frank Holcombe, Jr. cover stability case studies, application processing and content, and guidances. One of the top causes for RTR is stability problems. They cover inadequate and adequate stability submissions and the differences between FDA's and the International Conference on Harmonisation's (ICH) recommendations regarding stability data.
Learn more at www.fda.gov/dr...
_______________________________
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Visit www.fda.gov/cd... and www.fda.gov/cd... for news and a repository of training activities.
Email: [e-mail]
Phone: [phone] I [phone]
LinkedIn: / cder-small-business-an...
Twitter: / fda_drug_info
CDER small business e-mail update subscription: updates.fda.go...