Preparing Analysis Data Model (ADaM) Data Sets and Related ...
submission of NDAs and most BLAs to FDA CDER and CBER. The deliverables discussed are analysis datasets, other files related to analysis datasets, analysis programs, data definition files (define.xml) and the Analysis Data Reviewers Guide (ADRG). The material included here is based on requirements described in the two December 2014 FDA Binding ................
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