65 Food and Drug Law Journal, 425-446 (2010). Negotiated rulemaking is a regulatory tool designed to build consensus on regulations before notice and comment rulemaking procedures. An agency conve...read more
65 Food and Drug Law Journal, 317-346 (2010). No medical intervention comes without risks. Certain risks may be grave, but will only occur in a fractional percentage of cases. When does the disclos...read more
65 Food and Drug Law Journal, 37-66 (2010). The sequencing of the human genome and the revolution it has caused in biomedical science created hope for a new era in the prevention and treatm...read more
65 Food and Drug Law Journal 141-158 (2010). Pharmaceutical and medical device manufacturers contract with thousands of physicians each year, and struggle to comply with the Fair Market Value requ...read more
65 Food and Drug Law Journal 67-112 (2010). The Food and Drug Administration Amendments Act of 2007 (FDAAA) authorized the U.S. Food and Drug Administration (FDA) to develop a 100-million-p...read more
64 Food and Drug Law Journal 733-754 (2009). In governing the life sciences, there is a need to foster innovation, but also to control risk. While the scientific complexity and public unease with n...read more
64 Food and Drug Law Journal 599-630 (2009). At the turn of the century, newspapers across America carried reports of a handful of infant deaths in St. Louis linked to contaminated diphtheria vacci...read more
64 Food and Drug Law Journal 677-692 (2009). The world market for functional foods, nutraceuticals, and dietetic products has been expanding and is driven by demographic, economic, and social trend...read more
64 Food and Drug Law Journal 755-804 (2009). While this year is likely to bring major policy changes as a result of the potential health system reform legislation, the trends in agency activities a...read more
64 Food and Drug Law Journal, 631-662 (2009). This article examines the rules applicable to pediatric rewards and their interpretation by the competent European authorities, i.e. the European Commi...read more