More QbD Information is Better
This article was originally published in The Gold Sheet
Executive Summary
John Towns, director of global CMC regulatory affairs for Eli Lilly said on Sept. 24 at the joint PDA/FDA regulatory discussion on the ICH Q8 guideline in Washington that if the pharmaceutical industry is unclear about how much information should be put in a QbD filing, "more information is better than less in QbD. Convince your folks that putting in more information will not do you any harm.