Using SPL for Electronic Drug Establishment Registration & Drug Listing Submissions

As of June 1, 2009, the FDA requires establishment registration and drug-listing data in a fully electronic format known as structured product labeling (SPL). This guidance applies to all prescription pharmaceutical, biological, OTC, and veterinary medicine producers and distributors. The implementation of SPL will eliminate the creation of paper forms, which duplicated information already contained in product labeling.

As industry continues to provide more electronic labeling information, the FDA is able to decrease the amount of proofreading of paper submissions, thereby decreasing the chances of human error. This audio conference explores how SPL allows for electronic technology to capture this information, decreasing the potential for human error in transcription and increasing efficiencies.

Using SPL for Electronic Drug Establishment Registration & Drug Listing Submissions is being presented by Craig Trautman, CEO, with Intagras and airs on Tuesday, July 14, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com