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Communications

Press Center


Par Pharmaceutical Embraces Quark XML Author for SPL and Dynamic Publishing

A Strong XML Strategy Built on Quark XML Author Allows Anyone on Par’s Team to Create FDA-compliant SPL Submissions using Microsoft Word

DENVER - 8/24/2009 - Quark announced today the availability of a case study detailing Par Pharmaceutical’s use of Quark® XML Author for Microsoft Word to maintain compliance with the US Food & Drug Administration’s Structured Product Labeling (SPL) rulings. The case study is available here: http://dynamicpublishing.quark.com/xml_author/ParCaseStudy.html.

Case Study Overview
In 2005, Par Pharmaceutical faced the challenge of complying with the FDA’s SPL ruling that required drug product labels be submitted in XML. By mandating that pharmaceutical companies adopt XML, the FDA’s ruling was disruptive, adding cost and complexity to the process of bringing products to market. In response to the ruling, Par, a developer and manufacturer of generic and proprietary specialty drugs, turned to Quark for an in-house XML authoring solution that allows the team to achieve compliance quickly, easily, and cost-effectively.

As part of the evolution of SPL rulings, the FDA approved the Physicians Labeling Rule (PLR), which requires that content for product labels must not only be submitted in XML, but also in a specific format and layout. And most recently, the FDA issued SPL R4, a revision to SPL that mandates that starting June 1, 2009, all product label content must be submitted by pharmaceutical companies electronically in XML.

Quark’s case study highlights how Par, led by its resident XML expert Michele Cobham, has maintained compliance with the FDA rulings around XML-based labeling, drug registration, and labeler code registrations by bringing the conversion and creation of XML content in-house, rather than using an outside service.

To learn more about Quark XML Author for Microsoft Word, visit: http://dynamicpublishing.quark.com/xml_author/.
For more about the Quark SPL Accelerator, visit: http://dynamicpublishing.quark.com/xml_author/spl_accelerator_spl_authoring.html.

About Quark
Quark Inc. (www.quark.com) led the first revolution in publishing with QuarkXPress®, desktop publishing software that rapidly became the industry standard. Today, not only does QuarkXPress continue to innovate in the desktop publishing market, Quark is revolutionizing publishing again. With Quark® Dynamic Publishing Solution, we are helping customers meet changing requirements and develop new revenue streams by extending the benefits of advanced technologies across the publishing process. Our dynamic publishing solution is setting a new standard in automated multi-channel publishing by combining the power of flexible layout and design with easy XML authoring and automated workflows for customized communications across print, the Web and electronic media.

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Contact: Sarah Rector, Quark Inc., 303-894-3753, srector@quark.com