The federal Food, Drug and Cosmetic Act (FDCA) requires drug manufacturers to demonstrate to the Food and Drug Administration (FDA) both the safety and the effectiveness of their drugs for their intended uses in order to...
March 17, 2016
Losing Its Bite? The Erosion of FDA Power Over Promotion of Off-Label Drug Use
March 17, 2016
Managing Risks and Preparing for a Data Breach: Cyber Liability
The digital revolution has changed the way business is conducted, how people communicate, and the way private information is stored and maintained. The advantages of this technology outweigh the risk, but rest assured the...
March 17, 2016
The Evolution of California’s Regulation of Fire Retardants in Children’s Products
California is at the forefront of regulating children’s products, specifically those containing fire retardants. It is likely that in the next few years California will issue further regulations regarding...
March 17, 2016
An Offer You Cannot Refuse? Applying Costs Equally to Plaintiffs and Defendants
Effective January 1, 2016, the California Legislature equalized the treatment of expert witness costs that can be awarded to litigants under California’s Code of Civil Procedure Section 998. Section 998 is a mechanism...
March 11, 2016
FDA Issues Final Guidance Regarding Reducing Acrylamide in Certain Foods
On Thursday, March 10, 2016, the United States Food and Drug Administration (FDA) issued final guidance regarding steps that growers, manufacturers, and food service operators in the food industry can take to help reduce...