Tag Archive: intellectual property

Sep 09 2014

Drug Master Files (DMFs) in the United States, Canada, and European Union

By Amy S. Blawas, Ph.D., R.A.C., Associate Director of Pharmaceutical Development, Senior Scientist Cato Research Ltd. Recently, Cato Research has experienced an increased client activity in filing and maintaining Drug Master Files (DMFs) in the United States, Canada, and European Union. DMFs are a voluntary means for a contract manufacturer or supplier of an active …

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Nov 19 2012

Health Canada Orphan Drug Policy – A Long Overdue Need

Canada is one of the only first world countries without an orphan drug policy. The United States, European Union, Australia, Singapore, and Japan recognized a long time ago the importance of having established policies around the development of orphan drugs. In a 1996 report from Health Canada‚Äôs Drugs Directorate that analyzed the need for an …

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