Regulatory Affairs Certification (RAC) Practice Exam

Which circumstance does NOT warrant expedited review of an Original Abbreviated New Drug Application?

1. Products targeting a new subpopulation

2. Newly discovered efficacy in treatment

3. New delivery method of existing drugs

4. Drugs for severe medical conditions

The correct answer is: Products targeting a new subpopulation

Expedited review processes, such as those for Original Abbreviated New Drug Applications, are designed to facilitate quicker access to medications that address significant medical needs or new therapeutic benefits. The correct answer, which states that products targeting a new subpopulation do not warrant expedited review, is based on the understanding that simply targeting a previously identified subpopulation does not inherently indicate a significant advancement in safety or efficacy that would justify an expedited review. Expedited reviews are typically reserved for new formulations, delivery methods, or drugs that demonstrate newly discovered effectiveness against conditions, especially for patients with severe medical conditions where treatment alternatives may be limited. For instance, newly discovered efficacy in treatment, a new delivery method, and drugs intended for severe medical conditions all indicate significant enhancements or outcomes that could greatly benefit patient populations, which are vital for expedited review status. Targeting a new subpopulation alone does not necessarily imply that the drug offers better efficacy or safety compared to existing therapies, thus not warranting expedited assessment.