Whippany, NJ (October 24, 2006) - In response to the first major overhaul of US pharmaceutical product labeling requirements in more than 25 years, Image Solutions Inc announced today the availability of the latest version of its Document Authoring product, ISIWriter 2.0, as well as two related offerings designed to ease compliance and increase efficiency.. The new 275-page Food and Drug Administration rule took effect in July and compels drug companies to convert prescription drug labels going forward. It also requires that drugs approved since June 30, 2001, be changed over to the new format within seven years.

“We have announced important steps toward creating an electronic environment for drug safety and effectiveness information that can provide patients and healthcare professionals with critical information at the point of care,” acting FDA Commissioner Dr. Andrew von Eschenbachh said in a press release issued when new regulations were approved earlier this year.

But, while the Physician's Labeling Rule (PLR) creates a better and clearer medication label, it also increases the complexity for drug makers to create that document, said Peggy Boe, Director of Professional Services at ISI, a global technology company and an industry leader in providing innovative software solutions and services for electronic regulatory document submission and clinical trials management. To address this issue, ISI's new offerings take a two-pronged approach:

• A Microsoft Office Word™ template for labels compliant with the PLR is now available as part of the ISIWriter™ template package. It includes detailed instructions for constructing the labeling information and also provides the structure for all newly required content
  
• ISI's Structured Product Labeling (SPL) Conversion Service is based on technology that has been used in hundreds of label conversions to date and provides the ability to convert, review, edit and submit product information without having to learn how to program in XML. Only months after the FDA put the original SPL requirements into regulation, the Physician's Labeling Rule required a major update to the conversion process. ISI's conversion services are ready to handle these new labeling specifications and ease customer transition concerns.
  

"ISIWriter adds a layer of protection and control to Word documents, ensuring the kind of consistent formatting that is needed for drug product labels. The document control and repair capabilities in ISIWriter go far beyond simple templates with example content to create consistent, reliable scientific and regulatory content,” said Joel Finkle, PMP, Director of Product Strategy and Product Manager for ISIWriter.

ISIWriter 2.0’s new functionality also makes it easier for corporate customers to distribute settings to all users and store default values for document information fields and first-page headers and footers. In addition, the Options command can be locked from user access, making sure that only the company-approved defaults are used.

The new PLR requirements include a "Highlights" section at the top of the label which calls attention to the routine prescribing information for physicians and pharmacists, promoting safer use of prescription drugs and improving the utility and readability of label information. ISIWriter 2.0 is designed to greatly improve the safety of medicines by summarizing critical information in a prominent location on the label with consistent format, Finkle added.

ISI's service offerings include one-time conversion, a subscription to update all changes over the course of a year, knowledge-based quality control checks, and consulting services to help pharmaceutical companies prepare for and execute label conversions.

"Companies can continue to maintain their labels in Microsoft® Office Word, with the full knowledge that the conversion to PLR-compliant SPL performed by ISI will be complete, fast, and accurate, without the concerns of writing XML-structured code for labeling," Ms. Boe said. “Combined with ISIs reputation for quality assurance and knowledge of regulatory submissions and medical writing, ISI can now provide label conversion support, whether it's for a single label for inclusion in a new regulatory filing or for the mandated conversion of the hundreds of existing labels a large pharmaceutical company will have to deal with in order to comply with the latest federal regulations."