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
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