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: www.fda.gov/cdersbia
CDER SBIA 2020 Playlist: • 2020 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: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367
30 авг 2020