What type of information is typically found in a drug's section 505(b)(2) application?

A 505(b)(2) application is a unique type of regulatory submission to the FDA that allows for a combination of new drug application (NDA) data and existing data, such as published literature or studies that were not conducted under an Investigational New Drug (IND) application. This type of application is typically used for drugs that are similar to existing therapies but may have some differences in indications, dosages, or formulations.

The option referring to data from studies not conducted under an investigational new drug application is correct because it aligns with the regulatory flexibility provided by the 505(b)(2) pathway. This pathway allows sponsors to incorporate findings from non-IND data, such as international clinical study results or published literature, which can expedite the review process and support a marketing application by leveraging already available information on safety and efficacy.

In contrast, other options are more restrictive or specific than what is typically allowed in a 505(b)(2) application. For instance, restricting the application to results of Phase I clinical trials only does not encompass the broader data pool permissible under this pathway. Similarly, full clinical study reports from all trials are more extensive than what is needed for a 505(b)(2) application since it allows for a more diverse data