Regulatory Affairs Certification (RAC) Practice Exam

Which regulatory pathway is most applicable for a combination of individually approved drugs with no Reference Listed Drug?

1. Abbreviated New Drug Application (ANDA)

2. New Drug Application (NDA)

3. 505(b)(2)

4. Investigational New Drug (IND)

The correct answer is: 505(b)(2)

In the case of a combination of individually approved drugs with no Reference Listed Drug, the most applicable regulatory pathway is the 505(b)(2) application. This pathway is designed for situations where the product is a new combination of existing drugs that have already been individually approved. The 505(b)(2) application allows for the inclusion of data not generally required for a traditional New Drug Application (NDA). This can include existing literature or studies, enabling the sponsor to rely on previously submitted data related to safety and efficacy for the individual components while still addressing the specific combination being proposed. Moreover, because the drugs in this combination already have individual approvals, the regulatory agency can evaluate the new combination based on both the existing data and any new evidence submitted. This streamlines the process, facilitating market entry for combinations that may offer enhanced therapeutic benefits. In contrast, other pathways like the Abbreviated New Drug Application (ANDA) are not suitable here since ANDA is specifically for generic drugs and requires a Reference Listed Drug, which is absent in this scenario. The New Drug Application (NDA) is typically used for new, unapproved drugs, and an Investigational New Drug (IND) application is focused on conducting clinical trials rather than seeking market