Executive Summary

At the Sept. 24 joint PDA/FDA regulatory workshop discussion on the ICH Q8 guideline in Washington, which introduces the concept of design space, Moheb Nasr, director of the Office of New Drug Quality Assessment at CDER, said that "the more you understand [the drug product] at small-scale, the less you have to do at the commercial operation….I think you wind up reducing the costs in the long-run. The cost of QbD is much less than what people think." Nasr added that manufacturers who are confused about what to submit "when you're in the IND process for Phase 2, have a dialogue with the agency. We can provide free advice to you.