MedImmune’s Experience in the FDA QbD Pilot Program: The Story So Far…

MedImmune was accepted into the FDA Pilot Program in January 2011 and has had one meeting to date, in July 2012. The main topics of the first meeting were MedImmune’s overall strategy for Quality Attribute risk assessment and the specifics of our Severity assessment approach. An overview will be provided of MedImmune’s general QbD philosophy, the risk assessment approaches presented in the first FDA meeting, and the feedback received from the agency..