FDA Readies ICH Q12 Implementation Guidance, Learns Lessons From Pilot

 
• By Joanne S. Eglovitch

Upcoming ICH Q12 implementation guidance will translate terminology on post-approval changes into a US context, said a US FDA official who also shared some lessons learned on established conditions.

Manufacturing Flow chart
US FDA About To Release ICH Q12 Implementation Guideline • Source: Shutterstock

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