Just as in any sport where one is trying to score points, it does not matter how close you come to your goal, no amount of effort will achieve victory if you do not actually score points. We often hear of a team that “stranded X number of base runners” in baseball or “turned the ball over on the other team’s 2 yard line” in American football. In the pharmaceutical and biotechnology industries the equivalent situation is that your New Drug Application was completed, reviewed and then was not approved by the regulatory agency. We all realize that an New Drug Application must be approved by the regulatory agency to sell your product and help your company achieve its financial goals. Without regulatory approvals you cannot sell prescription drugs in the United States or in many other countries.

Many of the principles of regulatory affairs as well as some practical pointers and processes to keep in mind and use are presented in this section of the book. Another principle that is of particular importance and has always been known, but not always followed, is to be as clear, precise and accurate in your presentation of data, interpretations and discussions. Too often, a company’s final medical reports (and often toxicology reports) consist of a full presentation of data and all results, but are weak in interpreting these results. The discussion section too often merely rehashes the results without presenting the company’s interpretation. This omission allows regulatory agencies to form its own interpretation of the data without input from the company about what it believes to be the most appropriate interpretation and showing the evidence that supports this. Hopefully, there will not be any significant difference between the two interpretations, but this concordance is not one that may be assumed.