63 Food and Drug Law Journal 701-712 (2008). The discipline of pharmacovigilance is based on the reporting of a drug’s adverse events. The regulatory authorities in the developed world, led b...read more
63 Food and Drug Law Journal 585-592 (2008). This article contains the prepared text of remarks delivered at the 51st Annual Conference of the Food and Drug Law Institute, March 26, 2008. The paper...read more
63 Food and Drug Law Journal 439-458 (2008). In light of the Supreme Court's recent denial of certiorari in the Abigail Alliance case, FDA and Congress have an opportunity to advance clinical trial...read more
63 Food and Drug Law Journal 509-524 (2008). The U.S. Foreign Corrupt Practices Act (FCPA) prohibits improper payments by U.S. companies and others to foreign government officials to obtain or reta...read more
63 Food and Drug Law Journal 525-536 (2008). Federal regulations adopted 30 years ago prohibit sponsors of clinical studies from including waiver of liability provisions in informed consent documen...read more
63 Food and Drug Law Journal 593-600 (2008). This article contains the prepared text of remarks delivered at the 51st Annual Conference of the Food and Drug Law Institute, March 26, 2008. The paper...read more
63 Food and Drug Law Journal 391-406 (2008). Ethical considerations regarding individual health and welfare need not be carelessly disregarded during creation of policies aimed at protecting the&nb...read more
63 Food and Drug Law Journal 459-492 (2008). FDA's recent decision to send warning letters to several pharmacies compounding prescription drugs for "bioidentical" hormone therapy is the latest roun...read more
63 Food and Drug Law Journal 421-438 (2008). The learned intermediary doctrine provides that a prescription drug manufacturer fulfills its duty to warn by providing an adequate warning of the medic...read more
63 Food and Drug Law Journal 407-420 (2008). "Nanotechnology" expands across research domains, applications and products and remains a field with neither a single scientific definition nor a forma...read more