Abstract

The many types of drug product dosage forms are presented. Contemporary forms are discussed, as are technologies of design and manufacture to deliver safe and effective therapeutic responses each time administered. A brief outline of information that is available on the Web pertinent to the FDA and regulatory issues is given. The process of new drug approval and its continuous modification reflects both the progress of science and the globalization of the world’s economy. The reader is encouraged to follow the changes by constant monitoring of the FDA and the industry sites dedicated to these issues. The history of drug regulation in the United States, the evolving structure of the FDA, the steps to be taken in the process of obtaining the approval to market the new molecular entity, and the post-approval requirements are briefly described.