Published Works | Legal Times | 20 June 2005

Making Medicine Out of Us: Harmonizing U.S. and EU Rules on Human-tissue Products May Help Spark New Therapies

This article discusses the finalization of the U.S. Food and Drug Administration's comprehensive mechanisms for regulating human tissue products and the European Union's proposal for an analogous framework. Issues identified in the article include the need for regulators to harmonize the regulatory requirements for human tissue products.