Regulatory Affairs Certification (RAC) Practice Exam

Which statement about proprietary name approval for a new drug is FALSE?

1. The submission package can be submitted any time

2. The request must be submitted no later than the NDA

3. The name may need to be changed following approval

4. Approval can occur after NDA submission

The correct answer is: The submission package can be submitted any time

The statement regarding the submission package being able to be submitted at any time is false because there are specific timelines and regulations governing when a proprietary name submission must occur in relation to other submissions. Regulatory authorities, such as the FDA, typically require that the proprietary name approval request be submitted no later than the new drug application (NDA). This is to ensure that the proprietary name is evaluated alongside the drug’s safety and efficacy data, thereby providing an opportunity to address any potential issues related to the name early in the review process. Proprietary names must be carefully considered and are subject to various naming conventions and regulations, and sometimes those names may need to be changed after approval; however, the timing of the submission itself is crucial and not flexible. Therefore, it is necessary for sponsors to be proactive and submit their proprietary name request in alignment with regulatory timelines to avoid potential delays in the drug approval process.