Regulating molecular diagnostic assays: developing a new regulatory structure for a new technology.

Molecular diagnostics are playing an increasingly important part in the practice of medicine. However, molecular diagnostics have not yet made the clinical impact that many had predicted. Multiple factors affect the uptake and utilization of molecular diagnostics, including government regulation.

Litigating the legality of compounding: the medical center pharmacy case.

The question of whether all compounded drugs are "new drugs" has been disputed in the United states for over 15 years. The Federal Food, Drug, and Cosmetic Act generally requires that "new drugs" obtain U.S.