Using Define-XML for Dataset DesignIn the past, sponsors submitting to FDA were required to submit a PDF describing their submission datasets. As Share XUsing Define-XML for Dataset Designhttps://pharmaphorum.com/partner-content/using-define-xml-for-dataset-design/
Using SDTM, ADaM, and SEND for Regulatory SubmissionsUsing SDTM, ADaM, and SEND for Regulatory Submissions Share XUsing SDTM, ADaM, and SEND for Regulatory Submissionshttps://pharmaphorum.com/partner-content/using-sdtm-adam-and-send-for-regulatory-submissions/