In May 2015, FDA released a draft guidance on Established Conditions. This document provides guidance for postapproval changes and forms the basis for a risk based approach to lifecycle management. A main element of the ICH Q12 initiative is to define those established conditions where chemistry, manufacturing, and control (CMC) changes require regulatory submissions and approval.
The RAPS Philadelphia Chapter invites you to participate in a 90-minute webcast to help firms avoid problems in lifecycle management of small moleules. Topics to be covered include: