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

 
• By Bowman Cox

The ‘established conditions’ concept enshrined in the ICH Q12 draft guideline was the US FDA’s answer to the background information that has cluttered new drug applications in the quality-by-design era. But early indications are that it will amass information clutter of its own.

Stacks of paperwork and files in the office: work overload, files management and administration concept - Image
The US FDA will want new information about non-established conditions

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...

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