No. A DDT can be used in a drug development program without it going through the qualification programs. The use of non-qualified DDTs will be reviewed by the relevant CDER Division(s) as part of IND, NDA or BLA reviews.
Qualification is recommended for a DDT that has the potential to be used in multiple drug development programs. In this instance, qualification may reduce duplication of efforts, allow resource and information sharing, and facilitate regulatory acceptance of the DDT for future applications utilizing the same context of use.
