Overview of Post-approval Chemistry, Manufacture, and Controls (CMC) Changes to an NDA - REdI 2020

FDA discusses regulations and guidances for making post-approval changes, including ICH Q12 and comparability protocols. FDA also covers type of submissions to FDA for post-approval changes and opportunities available for guidance from FDA.

Presenter:
Hasmukh B. Patel, Director
Division of Post-Marketing Activities 1 Office of Lifecycle Drug Products (OLDP) Office of Pharmaceutical Quality (OPQ) | CDER

_______________________________
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 2020 Playlist:    • 2020 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