This article provides an observation on the five conditionally approved cases in 2023 and 2024. By reviewing the five cases from a procedural perspective, the authors examine the implementation of the newly introduced “stop-clock” mechanism and its possible impacts on the review process. This article also discusses other factors influencing the length of SAMR’s review period. In addition, this article, from a substantive standpoint, examines the key features and notable developments of the
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