Computer-assisted NDAs

Gender-related data from the FDA are more readily available as the FDA continues to increase its computer ability, and pharmaceutical firms utilize computer-assisted NDAs and increase their efforts to adequately power the studies to find differences. Unified systems and formats would enhance this. The information is included in the Summary Basis for Approval or in the Medical Reviewer s Report. Either should be available through the Internet at www.fda.gov./cder under New Approvals . 

Another example was the Computer Assisted NDA (CANDA). The Cardiorenal division within CDER embraced this technology rapidly and developed its own guidelines as to the technical parameters for this innovation. When the rest of CDER caught up (several years later), it was clear that consistency with an established and successful CANDA format was not on the agenda. 

The Computer Assisted NDA (CANDA) refers to the submission of data to the FDA in machine-readable form. At the present time, it is required that, at a minimum, the data from the carcinogenicity studies be submitted to the agency in a specified format that is available from the FDA. This allows the agency to apply its own criteria and statistics to the data and independently confirm the sponsor s conclusions. This agency review is then submitted to the FDA s Carcinogenicity Assessment Committee for final review and conclusions. 

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