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U.S. Department of Health and Human Services

Drugs

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Overview of the Office of Orphan Products Development: Incentives for Rare Diseases Webinar - October 18, 2011

The Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Small Business Assistance Program is delighted 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, October 18, 2011, we presented our webinar entitled Overview of the Office of Orphan Products Development: Incentives for Rare Diseases which discussed the Orphan Drug Act, the Office of Orphan Products Development (OOPD) programs including the grants and designations programs, and incentives for rare diseases.
 
Our presenter was Ms. Katherine Needleman who is a Health Science Administrator in the Office of Orphan Products Development (OOPD) where she serves as the Director for the Orphan Products Grants Program with responsibility for management of the $14 million OOPD extramural research budget. She works closely with project officers, researchers, and organizations to advance promising medical products to market approval, to increase the publication of significant findings in the scientific literature, and to oversee the responsible use of federal funds for clinical research.
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