The term “context of use” refers to a comprehensive description that fully and clearly delineates the limits of FDA’s qualification decision in terms of the manner and purpose of use for the DDT(s). The context of use statement should describe all criteria under which the DDT is qualified for use. The qualified context of use defines the boundaries within which the available data adequately justify use of the DDT(s). As data from additional studies are obtained over time, submitters of DDTs may continue working within the DDT Qualification Programs to submit additional data and expand the qualified context of use.
What is Qualification?
Qualification is a conclusion that within the stated context of use, the DDT can be relied upon to have a specific interpretation and application in drug development and regulatory review. Once qualified, DDTs will be publicly available to be used in any drug development program for the qualified context of use. The qualified DDT can be included in IND or NDA/BLA submissions without the need for CDER to reconsider and reconfirm the suitability of the DDT as long as:
* There are no serious study flaws
* There are no attempts to apply the DDT outside the qualified context of use
* There are no new and conflicting scientific facts not known at the time the qualification was determined
Qualification may contribute to acceptance and application of DDTs across multiple drug development programs. Having qualified DDTs that can be utilized by many sponsors will aid in optimizing drug development and evaluation.
These Qualification Programs promote a collaborative setting in which there are advantages for multiple interested parties to work together in a consortium to develop DDTs for qualification. Resources and knowledge-sharing outside a specific drug development program can accelerate DDT development and facilitate availability of DDTs at critical milestones for future drug development programs. Early and continued interactions with FDA during the DDT development process are critical to the success of these programs.
Regulators love ambiguity because it gives them power. But flexibility is important. All this to say, it’s a tough balance.
And, once again, context matters.