Before it can sell a prescription drug lawfully in interstate commerce, a manufacturer must prove to the satisfaction of the Food and Drug Administration that the drug is both safe and effective. Congress approved this requirement in 1962 unanimously. Four decades of changes in the drug market...

Food-borne illness remains a major public health challenge in the United States, causing an estimated 48 million illness episodes and 3000 deaths annually. The FDA Food Safety Modernization Act (FSMA), enacted in 2011, gives the Food and Drug Administration (FDA) new tools to regulate food...

Before a new drug can be marketed the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed...

This comprehensive food and drug law resource, “Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary and Tobacco Products Regulation,” is organized for ease of reading in order to comprehend a complex area of law....

Financial regulation is a much debated topic for some time. The history of financial instruments started at a time when people started giving value to physical objects over and above its inherent utility. Right from the very beginning of their existence, it has been acknowledged that financial...