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U.S. Department of Health and Human Services


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CDER Small Business Combination Products Webinar - February 28, 2012

The Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Small Business Assistance Program is pleased to inform you of a unique opportunity for small business entities to learn more about the FDA and basic drug regulation. Our webinar series will highlight various aspects of drug regulation.

These focused webinars will support the Program’s mission of promoting productive interaction with regulated industry by assisting regulated domestic and international small pharmaceutical business with information relating to the development and regulation of human drug products.

On Tuesday, February 28, 2012, we presented our webinar entitled Combination Products, which discussed the process of classification and assignment of combination products as well as development considerations.

Dr. Kristina Lauritsen was our presenter. Dr. Lauritsen is a scientific reviewer in the Office of Combination Products (OCP). She has been with OCP for the past 5 years, working primarily with informal and formal requests for designation. Prior to joining OCP, Dr. Lauritsen was a reviewer in the Office of Device Evaluation in the Center for Devices and Radiological Health. She joined FDA in 2003 as part of the Emerging Leaders Program in the Department of Health and Human Services.  Her education includes a Ph.D. in tumor biology from Georgetown University and a B.S. in biology from Shippensburg University.


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