Table 2.
Rationale for new approach to development of Drug Development Tools (DDTs).
| Points | Description |
|---|---|
| 1 | Once a DDT is qualified for a specific context of use, industry can use the DDT for the qualified purpose during drug development, and CDER reviewers can be confident in applying the DDT for the qualified use without the need to reconfirm the suitability of the DDT. |
| 2 | Because of the substantial work needed to achieve qualification, CDER encourages the formation of collaborative groups to undertake these tool-development programs to increase the efficiency of joint efforts and to lessen the resource burden upon any individual person or company working to gain qualification for a tool. |
| 3 | DDT acceptance in the drug development and regulation process has previously been on a sponsor-by-sponsor, drug-by-drug basis. |
| 4 | If a DDT is qualified under this guidance, the qualified DDT will be made publicly available for use by sponsors of any drug or biologic investigational new drug (IND) or new drug application (NDA) or biologics license application (BLA). |
| 5 | The new guidance is intended to provide some degree of generalizability for use of the tool such as use across multiple clinical disorders, multiple drugs, or drug classes. |