ADaM Review from a CDER Statistical Reviewer's Perspective
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The U.S. Food and Drug Administration and CDISC are currently working together to develop standards for NDA/BLA analysis data submissions. This session will provide the audience with insights into the regulatory review of NDA/BLA analysis data with an emphasis on reviewing analysis data modeled utilizing CDISC/ADaM. The session will discuss what regulatory reviewers are currently learning about analysis files based on ADaM implementation while also discussing reviewers’ likes and dislikes regarding the model.