There are two major ways used to discuss the overall costs of bringing a new drug to the market. First, the cost of all failures and all successes over a period of time are totalled, averaged and then presented as the cost of a single success. The other approach is to solely determine the discovery, development and other costs of only one specific drug that is brought to the market. Both ways are important to understand as each has its own specific and legitimate uses.

When words like "compliance" and "risk" are used, does everyone reading the text or listening to the presentation understand which definition is being used? These and many other words have a variety of definitions, particularly for those with different perspectives and positions.

According to regulations, new drugs do not have to be better than currently marketed drugs in their degree of safety or efficacy. However, some regulators forget this and have to be reminded. If safety or efficacy is not quite as good as a marketed drug the other component must greatly exceed current therapy for the benefit to risk ratio to be positive in comparison to currently approved therapy.