Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods

Chapter 51

The FDA and Regulatory Issues

W. Janusz Rzeszotarski

51.1 Caveat

The reader is reminded that all the information that is provided in this chapter is freely available on the Web from the government and other sources and, subject to change. Instead of a bibliography, only the hyperlink sources are included in text, and the reader is advised to check them frequently.

51.2 Introduction

“The problem is to find a form of association which will defend and protect with the whole common force the person and goods of each associate, and in which each, while uniting himself with all, may still obey himself alone, and remain as free as before.” So wrote Jean Jacques Rousseau, Citizen of Geneva, in The Social Contract or Principles of Political Right (1762) (http://www.blackmask.com/books10c/socon.htm). His teachings were well known to the Founding Fathers. The Miracle at Philadelphia, the Constitutional Convention of May–September 1787, so gloriously described by Catherine Drinker Bowen, established federalism in the United States and provided for regulation of commerce between the states.

The progress of federalism was slow, and a trigger was needed. On the 25th of April 1846, Mexican troops crossed the Rio Grande to attack U.S. dragoons; this provided an excuse for the U.S.-Mexican war of 1846–1848. The state of medical support for the U.S. troops in Mexico was appalling, the drugs imported for them, counterfeited. In reaction to these events the U.S. Congress passed the Drug ...