Philadelphia, PA, USA-London, UK - July 22, 2005 - Thomson Scientific today announced that by utilizing Liquent CoreDossier®
in conjunction with the Liquent Consulting Services Organization, Dow Pharmaceutical
Sciences successfully obtained FDA approval for their new Rosacea treatment product
submitted via a full electronic Common Technical Document (eCTD). The submission
using these publishing solutions is the first eCTD to obtain approval through
the FDA's Division of Dermatologic Drugs. This milestone supports a trend in providing
regulatory agencies with submissions in electronic format, which is resulting
in a more efficient review process.
"We are pleased the FDA has approved our product within the first 10 month
PDUFA review cycle and 38 months after the initial IND submission" said
Barry Calvarese, Dow's vice president of Regulatory and Clinical Affairs. "This
approval validates our focused commitment to fast-paced topical product development.
It also demonstrates our ability to integrate and manage all aspects of development,
including formulation, CMC, regulatory and clinical affairs, and clinical trials
utilizing our clinical research sites in California and Germany.”
“The CoreDossier platform coupled with Thomson Scientific expertise
has helped us to bring this product to market faster and more cost effectively,”
Calvarese added. “Together we have achieved our goal of demonstrating
the benefits of the eCTD.”
“Dow Pharmaceutical Science’s success validates the decision by
more than three-quarters of respondents to the annual Liquent 2005 Regulatory
Submissions Trends survey, who stated their intention to migrate to the eCTD,”
said Jim Nichols, vice president of Product Strategy and Marketing, Liquent.
Companies using Liquent eCTD solutions are perfectly positioned to respond to
this planned migration by utilizing the most modern, comprehensive and intuitive
solution to handle these publishing demands.”
As part of an ongoing commitment to the hundreds of life sciences companies
that rely on its technologies to control the production and publishing of their
electronic documents, Thomson Scientific has announced that it is offering InSight
Publisher free of any license fee to all existing CoreDossier
and EZsubs clients as part of their maintenance agreements.
