Regulatory Publishing Considerations for Literature References

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eCTD submissions frequently include literature references that are submitted to support aspects or statements made within the application. The articles that are provided in the submission are typically from scientific or medical journals that have been downloaded by the sponsor from sources such as the publisher or a service provider like Thomson Reuters. Downloaded articles are commonly formatted following a set of standards that do not necessarily comply with the FDA PDF Specifications. For example, there may be non-standard fonts that are embedded, there could be securities enabled in the file, or it may not contain any bookmarks or hyperlinks. Some sponsors may have business processes to include top-level bookmarks in articles, or make other modifications to try to bring the file closer to meeting the PDF specification.

Many sponsors believe they should not alter other organizations’ files. Consequently, FDA reviewers have grown accustomed to these deviations from the specification when submitting this material in an eCTD. Accordingly, it is not necessary to modify or enhance literature references in order for them to become compliant for inclusion in the eCTD submission. It is okay to publish files if the business chooses to do so, but it also okay to submit them without performing any additional publishing.

Author: Emily Onkka

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