Regulatory Affairs Certification (RAC) Practice Exam

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Which pathway would NOT be appropriate for a combination therapy approval?

New Drug Application (NDA)
505(b)(2) application
Abbreviated New Drug Application (ANDA)
Investigational New Drug (IND)

The correct answer is: Abbreviated New Drug Application (ANDA)

The choice of an Abbreviated New Drug Application (ANDA) is not appropriate for the approval of combination therapies. ANDAs are specifically designed for generic drugs and must demonstrate that the proposed generic product is bioequivalent to an already approved reference listed drug. This pathway does not accommodate the complexities associated with combination therapies, which may involve multiple active ingredients and require different considerations regarding safety and efficacy that are not addressed through the generic approval process. In contrast, a New Drug Application (NDA) is suitable for a combination therapy because it allows for a comprehensive review of safety and efficacy data for the new combination being proposed. A 505(b)(2) application also provides a pathway to seek approval for a combination therapy by allowing the use of some existing data from previously approved drugs, which can be advantageous in demonstrating efficacy and safety without needing all the traditional data required for an NDA. An Investigational New Drug (IND) application is relevant for starting clinical trials for the combination therapy, focusing on the investigational nature of the products before they are approved for marketing. Thus, the ANDA, designed strictly for generic products, is distinct from pathways that address the complexities of combination therapies and is not suitable for their approval.