ABSTRACT
This chapter describes the Food and Drug Administration (FDA's) origin and its organization, followed by a description of some of the standards that have been either adopted or developed to address critical technical issues in drug delivery systems (DDS). It provides an overview of the FDA regulatory pathways involved in the regulation of DDS and a brief overview on micro- and nanotechnologiesm which are predicted to play a critical role in the future of DDS. One of the most important issues in drug therapy is the route of administration that determines the onset of action of the drug and some side effects that are specifically related to each route. Several routes of administration are available in the human body with an amazing repertoire of DDS developed for each one of them. A first classification of DDS is based on the different timing/rate of release, dividing oral DDS into immediate-release and modified-release DDS.
