CLAREMONT, Calif., Dec. 9 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has announced the launch of an orphan drug workshop series--an opportunity for biotechnology companies, pharmaceutical firms, academics and other interested parties to spend two days creating applications for orphan status designation, under the guidance of staff from FDA’s Office of Orphan Products Development (OOPD). The first workshop is planned for Feb. 25-26, 2010, hosted by the Center for Rare Disease Therapies at Keck Graduate Institute (KGI) in Claremont, Calif.
There will be an introductory presentation, but most of the time over the two-day period will be spent writing an application for orphan designation for specific products, which will be submitted at the close of the workshop.
For information about the workshops, contact Lucienne Nelson at lucienne.nelson@fda.hhs.gov or 301-827-3666.
KGI BACKGROUND
Educating the future leaders of the bioscience industry, Keck Graduate Institute (KGI) offers an interdisciplinary graduate education through its Master of Bioscience (MBS), Postdoctoral Professional Masters in Bioscience Management (PPMBS), PhD programs, and other degrees. Using team-based learning and real-world projects, KGI’s innovative curriculum seamlessly combines applied life sciences, bioengineering, bioethics and business management. KGI also has a robust research program concentrating on the translation of basic discoveries in the life sciences into applications that can benefit society. KGI is a member of The Claremont Colleges, located in Claremont, California.
Keck Graduate Institute
