Articles tagged with “post-approval-changes”

Biologics Comparability: A Guide to ICH Q5E & CMC Changes

An educational guide to biologics comparability studies. Learn how to prove "no meaningful change" after manufacturing process changes, based on ICH Q5E and FDA

50 min read

1/6/2026

comparability study biologics ich q5e cmc manufacturing changes regulatory affairs analytical characterization post-approval changes