In April 2000, European Regulation (EC) No 141/2000 on Orphan Medicinal Products, which, following the U.S. example, had been adopted to boost the research, development, and marketing of medicinal ...read more
The responsible corporate officer (RCO) doctrine permits convictions of corporate officers for violations of the Federal Food, Drug, and Cosmetic Act (FDCA), even in instances in which the corporat...read more
FDA's recent use of the Application Integrity Policy (AIP), most notably in the ongoing Ranbaxy matter, has created interest in the policy. The article discusses actions CDER's Office of Compliance...read more
Against a backdrop of steady deregulation, the pharmaceutical industry is increasingly outsourcing manufacturing, resulting in decentralized control of the global supply chain. Established pr...read more
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