Assembling Analysis Data For NDA and BLA Submissions To The FDA

The submission of New Drug Applications (NDAs) and most Biologics License Applications (BLAs) to the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) requires a meticulous assembly of analysis data and related files. This paper offers an in-depth look into the process of compiling these crucial elements, adhering to the guidance provided by the FDA and other regulatory bodies. The key deliverables discussed here include analysis datasets, related files, analysis programs, data definition files (define.xml), and the Analysis Data Reviewers Guide (ADRG).

Before delving into the assembly process, it’s crucial to comprehend the meaning of “analysis data” and other related data.

The Analysis Data Model Implementation Guide (ADaMIG) v1.1 describes three distinct types of datasets: analysis datasets, ADaM datasets, and non-ADaM analysis datasets:

A figure in the ADaMIG v1.1 document elucidates the relationships among these types of datasets, illustrating that an analysis dataset is either an ADaM dataset or a non-ADaM analysis dataset.

ADaM datasets are classified into three standard structural classes:

There could be instances where none of the standard structures can address a particular analysis need. For instance, none of the standard structures can generate a correlation matrix of time-varying dependent variables. In such a scenario, the unmet analysis need can be catered to by designing a dataset with a non-standard structure

Such a dataset qualifies as an ADaM dataset only if it adheres to all of the ADaM fundamental principles and other ADaM conventions. These ADaM datasets, which cannot follow a standard ADaM structure, are considered part of the ADaM Other class of ADaM datasets.

A non-ADaM analysis dataset refers to any analysis dataset that is not compliant with ADaM. Unlike ADaM datasets, non-ADaM analysis datasets do not have designated structures or classes.

The process of assembling analysis data for NDA and BLA submissions necessitates the preparation of datasets, be they ADaM or non-ADaM, that will be used for analysis and reporting. This involves the following steps:

Besides the analysis datasets, other files related to the analysis datasets also need to be compiled for the submission. This includes analysis programs, data definition files (define.xml), and the Analysis Data Reviewers Guide (ADRG).

Assembling analysis data for NDA and BLA submissions to the FDA is a complex process that requires a thorough understanding of the different types of datasets and the standards or principles they should comply with. It also involves the preparation and documentation of related files, including analysis programs, data definition files, and the Analysis Data Reviewers Guide. By following the guidance provided in the relevant FDA documents and adhering to the principles outlined by the ADaMIG, companies can ensure that their submissions are complete, compliant, and ready for review by the FDA.

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