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Topics that were addressed during the meeting included: Overview of the SE and PMTA process, changes since the SE and PMTA final rule implementation, and program status Required content and format for PMTAs Reviewed issues related to product characterization, nonclinical science, abuse liability, and population health FDA presented information about the SE and PMTA process including process improvements, and observations that may inform further improvements in submissions and the review process

30 (Suppl 2): 16974

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