Why ‘Established Conditions’ CMC Approach Could Generate More Supporting Information, Not Less

It turns out that as sponsors begin submitting drug applications that describe the "established conditions" of their manufacturing process that are subject to regulatory review per US Food and Drug Administration guidance, the agency may be more focused instead on the non-established conditions.

It is reminiscent of the situation a decade ago as the quality-by-design paradigm took hold, when FDA reviewers paid special attention to quality attributes and process parameters that applicants claimed...