Thomson offers label conversion to meet new FDA regs
allow pharmaceutical companies to quickly create and modify drug
labels that comply with new US Food and Drug Administration
guidance due to come into play this year.
The FDA's Structured Product Labelling (SPL) guidance published last year, was drawn up to help companies comply with regulations that came into force in 2003 requiring that all labels from medicines should be filed with the agency in electronic format.
The aim is to make it easier for the FDA to process, review, and archive the information, which should also speed up approval and create a standard format for labels which should make the information they contain easier to interpret and, as a result, reduce the risk of medication errors.
By mid-to-late 2005, the FDA wants to receive prescription product labelling electronically in XML format. So pharmaceutical companies now face the challenge of converting existing labelling to SPL format, producing new labels that comply, and managing the information they contain at a much greater level of detail.
Thomson claims that its new label conversion and creation service will enable pharmaceutical companies to submit labelling and immediately go to market with labels in the impending FDA-required format.
It is based on the use of Liquent Direct and Liquent InSight Manager, regulatory software systems already widely used for the creation of electronic dossiers used to file for product approvals in the pharma sector. Thomson, which specialises in a rangenof healthcare publishing including the US Physician's desk Reference, acquired Liquent as part of its merger with Information Holdings last year.
Once approached by a company, Liquent's regulatory specialists will use these proprietary packages to quickly convert their labels into the standard format. Once converted and checked for accuracy, companies can then go through their normal quality assurance and approval cycles, according to the firm.
"Liquent has an established history of document handling and transformation. Now, as a part of Thomson, we can work with our PDR colleagues to offer an end-to-end labelling solution from creation to dissemination of prescribing information," said Jay Nadler, president and CEO of Liquent and senior vice president of Thomson Scientific.
