Data presentations for FDA submissions

Data Presentation for FDA Submissions Text and Tabular Exposition... 

As preparations for the submission of an NDA begin, there needs to be a pre-NDA meeting with the EDA reviewing division. This meeting focuses on format, not content, and is important to eliminate delays that can occur when an NDA does not meet the specific needs of the assigned reviewers at the EDA (21 CER 312.47). The sponsor should provide to the FDA an idea of the t)q)es and volume of information to be submitted, as well as the plan for data summary, presentation and analysis. The FDA should provide to the sponsor any specific requests for the display and analysis of data. Electronic formats and requests have become more routine, and a good understanding of what is plaimed and needed can help improve efficiency and minimise later difficulties. 

Most NDA submissions contain an enormous amount of data, which cannot be presented entirely within the body of a document. Although all the data collected for an individual subject or patient (or groups of subjects or patients) may be important, critical judgment must be exercised in the selection of key data for presentation and discussion within a given document. Data necessary for the development of a specific thesis should be presented within the body of the document rather than placed into a remote appendix, which will impede the review. Less important data can be summarized briefly, clearly referenced in text, and placed in appendices. Additionally, data that have been collected over the years of a drug s development but add nothing to the evaluation of the effectiveness or safety of a therapeutic agent need not be presented at all. Any data submitted will have to be evaluated, so the inclusion of extraneous data will slow the review of the application. The submission should note the existence of such data and have it available upon request of the FDA. 

The general objective of the guidelines originates in the very early 1970s, when one pharmaceutical company in particular and a contract research organization (CRO) generated data that, when submitted to the FDA, gave them cause for concern in the accuracy of the data presented and, in certain instances, the honesty of the submission. 

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. 

Portrait tables are always preferable to landscape tables. Remember that the volumes in a submission will be about 2 inches thick. It is cumbersome, annoying, and disruptive for an FDA reviewer to have to move the volume around repeatedly to coordinate the text presentation with the tabular data. If data appear not to fit in the portrait orientation, try changing the axes of the table, so that the axis with more individual descriptors is vertical, whereas the axis with fewer items is horizontal (column headings). Also consider revising the table into separate sections under the same column headers, with descriptive headings for each section spanning the width of the table. 

Administration (FDA) guidelines in the same year (4). In 2001/ the General Accounting Office (GAO) report stated that while the number of women in clinical trials improved/ the FDA needs to do better in terms of effectively overseeing that studies actually compile and present data according to sex (6). For instance/ out of 300 new drug applications submitted to the FDA between the years of 1995 and 2000/ only 163 had sex analysis as part of the submission. Sex-based pharmacodynamic assessment was done for just 39 of 122 new medical entities (7). 

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