FDLI

First Prize, Short Paper, H. Thomas Austern Memorial Writing Competition, 2011. The current system of regulating the multi-billion-dollar pharmaceutical industry via market exclusivity comes from ...read more

Implementation of REMS began in March 2008 and by mid-2011 close to 200 New Molecular Entities (NMEs) and New Drug Applications (NDAs) (i.e., NMEs plus new doses and formulations of drugs) approved...read more

First Prize, Long Paper, H. Thomas Austern Memorial Writing Competition, 2011. Government-provided exclusivity periods provide pharmaceutical companies with incentives to invest in new drugs....read more

In an ongoing dispute, FDA asserts that autologous cultured stem cells used in treatments for orthopedic conditions are drugs and biological products subject to licensing and good manufacturing pra...read more

This article discusses how the Food and Drug Administration has come to adopt informal guidance (agency advice that influences regulated entities but does not carry the force and effect of law) as ...read more

Imagine a pill that, after you swallow it, can track its position in your body. Or imagine a pill that can transmit a message to a doctor to tell him that you have taken your bitter medicine. Pills...read more

In 1984, Congress passed the Hatch-Waxman Act, a landmark statute designed both to encourage innovation by pioneer drug companies and to increase competition by generic drug companies. After its en...read more

The rise in food importation in countries such as the United States, coupled with food safety incidents, has led to increased concern with the safety of imported food. This concern has prompted dis...read more

During this period, FDA focused considerable effort on its transparency initiative, which is likely to continue into the coming year, as well as continuing to ramp up its enforcement activities, as...read more

65 Food and Drug Law Journal, 247-284 (2010).   In Wyeth v. Levine, decided in March, 2009, the United States Supreme Court concluded that the plaintiff ’s failure to warn claim against ...read more