ABSTRACT
CONTENTS 26.1 Introduction ......................................................................................................................481 26.2 Labeling ..............................................................................................................................481 26.3 Labeling Changes ............................................................................................................482 26.4 Conclusion ........................................................................................................................482
Electronic labeling submission of drug marketing information using the structured product labeling (SPF) format is now mandatory by the FDA since 2005. The SPF has now replaced the portable document format (PDF) as the standard acceptable submission form. The change from PDF to SPL has many advantages, one of which is to meet the new mandates in the new Medicare Prescription Drug Law. This new mandate will expedite the FDA’s processing, reviewing, and archiving of the labeling content.
