The information in this workshop helps to create and maintain a drug master file which provides a seamless interface with the New Drug Application it is intended to supplement. One outcome of the workshop was the White Paper on Type III DMFs, suggesting methods of creation and maintenance. Another is a summary of the questions, opinions and concerns expressed by participants in break-out sessions. All of these are offered to FDA for their use in preparation of any guidance they choose to create. They are available for immediate use in improvement of your existing DMFs.

The workshop had six tracks. Track A, a plenary session, introduced the workshop and included presentations on the administrative aspects of creating and using drug master files. Track B, also a plenary session, was a series of presentations on specific features of DMF Types II, IV and V, plus the basics of food contact requirements.

Track C, was a plenary session about Type III DMFs. A White Paper for Type III DMFs was presented there, as was a talk on international submissions. Track D was a series of concurrent break-out sessions devoted to answering questions and obtaining input on DMF issues. A Q&A tutorial on DMF creation and maintence was held as well. Track E was a second round of break-out sessions and another Q&A tutorial.

Track F included a summary of the results of the break-out sessions, and a keynote address, "Vision for the Future of DMF Use", followed by discussion panels representing vendors, users and FDA responding to issues raised during the workshop.