FDA03
Using SASŪ Macros to Construct Items 5 and 11 of an Electronic Submission
Elizabeth Dennis, Quintiles, Inc.
Jay Zhou, Quintiles, Inc.

The Food and Drug Administration (FDA) has set forth guidelines to which companies must adhere when submitting New Drug Applications (NDA) electronically. These guidelines are changing the way companies view the preparation of an NDA, and they should chan ge the way statistical programming teams view their tasks. The team should no longer view their job as merely producing tables and listings, but in producing output that facilitates an electronic submission. Many of the requirements of Items 5 and 11 o f an electronic submission can be produced using SAS. To meet these requirements, three SAS macros have been developed. These macros can be used individually to generate specific components of the submission. They may also be combined with pre-programmi ng specification documents to further ease the construction of output suitable for Items 5 and 11.