62 FOOD AND DRUG LAW JOURNAL 343-348 (2007). On January 1, 2007, the International Federation of Pharmaceutical Manufactures and Associations (IFPMA) enacted an updated version of the Code of Pha...read more
60 Food and Drug Law Journal 495-510 (2005). Since President George W. Bush took office in 2000, the Food and Drug Administration (FDA) has used amicus curiae briefs in medical device and pharma...read more
Drug approval is the goal of the long process of drug development. Once preclinical, clinical, and chemistry manufacturing and control data have been collected, a new drug application must be submi...read more
60 Food and Drug Law Journal 375-392 (2005). This article describes recent changes in European Community (EC) legislation on the labeling of ingredients in foodstuffs that may trigger allergic re...read more
60 Food and Drug Law Journal 393-406 (2005). Effective food safety programs are vital in all parts of the world in order to reduce the burden of illness and to promote the trade of safe food prod...read more
60 Food and Drug Law Journal 347-360 (2005). As the U.S. Food and Drug Administration (FDA) becomes part of a globalized world enforcement process, Americans need to consider whether regulatory p...read more
60 Food and Drug Law Journal 361-374 (2005). Before 1990, food products bearing organic labels transacted in largely unregulated markets; since 1990, many countries have established labeling stan...read more
60 Food and Drug Law Journal 421-446 (2005). This article analyzes the legal flaws and the possible challenges of the Seventh Amendment Directive under European Union (EU) law. It begins with a b...read more
60 Food and Drug Law Journal 459-470 (2005). The aim of the provisions of An Act To Amend The Patent Act and the Food And Drugs Act (The Jean Chrétien Pledge To Africa), which contain sign...read more
60 Food and Drug Law Journal 453-458 (2005). In June 2005, the California Court of Appeals for the Sixth Appellate District, comprising the county of Santa Clara in the Silicon Valley, held that ...read more