Which type of application allows for drug approval based on investigations not conducted by the applicant?

The 505(b)(2) application is designed to allow drug approval based on investigations not conducted by the applicant. This type of application offers a pathway to approval for drugs that may rely on existing clinical studies, published literature, or other data to demonstrate safety and efficacy rather than requiring the applicant to conduct all new clinical trials. It is particularly useful for products that are similar to existing drugs and can leverage previous findings to support approval, thereby streamlining the development process.

This flexibility is part of what distinguishes the 505(b)(2) application from other types of drug applications. In contrast, an Abbreviated NDA is typically used for generic drugs and requires that the applicant conduct the necessary studies to demonstrate equivalence to a reference product. The Traditional 510(k) and Special 510(k) are pathways primarily for medical devices, not drugs, and are focused on demonstrating that a device is substantially equivalent to an existing, legally marketed device. Thus, these pathways do not facilitate drug approvals through reliance on external studies in the same manner as the 505(b)(2) application does.