Which of the following would require a Type A meeting with the US FDA?

A Type A meeting with the US FDA is typically held to address urgent and critical issues that can significantly impact the development or approval processes for a drug. This type of meeting is often necessary when there are unresolved issues that require expedited intervention from the FDA, particularly concerning disputes or conflicts that could delay a project.

In the context of this question, a dispute resolution represents a situation where differing opinions or issues arise between the sponsor and the FDA regarding the regulatory process or study outcomes. Such a scenario could necessitate a Type A meeting to facilitate prompt and effective resolution of the disagreement, ensuring that development timelines are not adversely affected.

Conversely, the other options, while they may involve interactions with the FDA, do not inherently require the urgency associated with Type A meetings. For example, clinical trial initiation typically follows an already established agreement and approval, so it does not need the immediate resolution aspect that a dispute would. Post-market study findings generally involve ongoing communications rather than urgent decision-making. Labeling changes, while important, are usually managed through routine regulatory processes rather than requiring a Type A meeting unless they are particularly contentious. Therefore, the option that aligns with the necessity for a Type A meeting due to its critical nature is dispute resolution.