Author: M.A. Holovac
This article reviews the range of laws and requirements that surround the creation, testing and marketing of
pharmaceutical materials in the USA. It focuses in particular on the
Orange Book-more formally Approved Drug Products with Therapeutic Equivalence Evaluations-and its role in the process of providing safe and effective drugs at reasonable cost for the consumer, while ensuring that the corresponding research and development in creating new drug products is rewarded. Specific topics covered include: the history and purpose of the `Orange Book', the legislative background, safety and effectiveness, therapeutic equivalence, Waxman-Hatch legislation, the patent position, various forms of…
