The FDA Modernization Act of 1997

In 1997, Congress passed legislation amending the Federal Food, Drug, and Cosmetic Act relating to the regulation of food, drugs, devices, and biological products. The new legislation, called the Food and Drug Administration Modernization Act, reduces the approval time for drugs and medical devices while maintaining patient safety. In addition, the Modernization Act provides the U.S. Food and Drug Administration (FDA) with additional resources to devote to expediting the drug and medical device review process.

The Cigarette Labeling and Advertising Act and

The Cigarette Labeling and Advertising Act (CLAA) was passed by Congress in 1965 to make Americans more aware of the adverse health effects of smoking. The CLAA requires health warnings on cigarette packages. As amended by the Comprehensive Smoking Education Act, the CLAA requires cigarette packaging to contain one of four specific labels warning of the adverse health effects of cigarette smoking. Warning statements must also be included in newspaper, magazine, transit and outdoor advertising. Cigarette advertising is banned from radio and television.

Cellular Phone Radiation

Cellular phones are hand-held wireless telephones that have a built-in antenna. Cellular phones are regulated by the Federal Communications Commission (FCC) and the Food and Drug Administration (FDA). The FCC sets safety guidelines that limit radiofrequency energy on wireless phones sold in the U.S. The FDA monitors the health effects of cellular phone use. Cellular phone use has skyrocketed. There were 16 million cellular phone users in the United States in 1994. By 2001, there were more than 118 million cellular phone users. This article focuses on the FDA's regulation of cellular phones.

Direct-to-Consumer Advertising of Prescription Drugs

What is the learned intermediary doctrine?

Possible Defendants in Product Liability Actions

Product liability laws protect consumers from unsafe products. What happens if a consumer doesn't know who manufactures the product? Can anyone else be held liable? What about sellers, resellers, assemblers, and manufacturers of component parts? Can anyone in the product chain from conception to purchase be held liable for a product's defects? Can anyone in the product chain be held liable for all of the damages of an injured consumer?