Michelle McGuiness Receives FDAs Commissioners Special Citation
WAYNE, PA - May 10, 2005 - Octagon Research Solutions, the leader in the electronic transformation of clinical R&D, announced today that Michelle McGuinness, Director of Product Strategy, is a recipient of the Food and Drug Administration's Commissioner's Special Citation (CSC). The citation recognized the Health Level Seven Structured Product Labeling Working Group for their work developing the "SPL Implementation Guide for FDA Content of Labeling Submission."
As a member of the Structured Product Labeling Working Group, Ms. McGuinness worked with other industry professionals to draft the companion guide that offers additional information for creating Content of Labeling submissions for the FDA described in the guidance to industry: Providing Regulatory Submissions in Electronic Format – Content of Labeling.
Jim Walker, president and CEO, Octagon Research Solutions, commented, "We are very proud of Michelle's contribution to the SPL Working Group. There are numerous industry standards evolving around submission documents and data. Michelle's strong technical knowledge, regulatory expertise and active participation in standard-setting activities continues to position Octagon at the forefront of changing the way industry gets products to market."
Dr. Lester M. Crawford, Acting Commissioner of Food and Drugs, presented the honor awards while being assisted by other FDA Senior Staff. The awards ceremony was held May 6, 2005 in Gaithersburg, Maryland.
The CSC was established as an expression of the Commissioner's personal appreciation recognizing outstanding and significant service in the public interest related to the activities of the FDA.
About Octagon Research Solutions, Inc.
Octagon is a leading process-centric solutions provider that offers a suite of regulatory, clinical, process and IT solutions to the life sciences industry. Octagon synchronizes processes and increases automation to reduce island-to-island inefficiencies within the clinical research and development process. We leverage the power of electronic submissions through cross-functional eSub expertise, a holistic process approach, deep domain knowledge and creative use of technology. Octagon is headquartered in King of Prussia, PA, with an office in Boston, MA. For more information please visit www.octagonresearch.com.
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