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Celsense, Inc Files FDA & EMEA Regulatory Submissions
Date:10/12/2009

FDA accepts Drug Master File and EMEA receives Active Substance Master File for Cell Sense in vivo imaging agent

Pittsburgh, PA (Vocus) October 12, 2009 -- Celsense, Inc. announced today it has reached a critical milestone in the push to market for its lead in vivo imaging reagent, Cell Sense CS-1000 (Cell Sense).

Celsense filed a Drug Master File (a “DMF”) with CBER earlier this year which the Agency has now accepted. An FDA Drug Master File provides key information about the quality of components, materials and manufacturing processes involved in producing medical devices and human drugs, including related products such as imaging reagents like Cell Sense. The main objective of a DMF is to support the filing and obtaining of Investigational New Drug Applications (INDs) by investigators incorporating the use of Cell Sense in their clinical trial.

Additionally, Celsense last week submitted an Active Substance Master File (ASMF) with the European Medicines Agency (EMEA) serving the same function within the European regulatory framework and assisting European investigators in similar fashion.

“Having these regulatory filings available for investigators to reference in their clinical testing applications is critical to the rapid and widespread adoption of our in vivo imaging reagents,” said Charlie O’Hanlon, company President and CEO.

Indeed, the company announced earlier this year that the company was one of the recipients on a 4-year $1.95M grant from the National Institutes of Health intended to fund the first studies to evaluate

Source: PRWeb
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Celsense, Inc Files FDA & EMEA Regulatory Submissions
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