ABSTRACT
The development of inhaled products in modern times has driven enormous innovation that has increased exponentially since the turn of the Millennium. Regulatory agencies are tasked with ensuring the quality and the safety of new drug products and equivalent, or generic, products. The two major organisations developing and promulgating standards in the United States are the US Pharmacopeia (USP) and the Food and Drug Administration (FDA). The USP, established in the nineteenth century, is the oldest standards document and is intended to establish the quality of products in commerce through monographs and test procedures. The FDA was established in the early twentieth century to assure safety of products through review procedures approval criteria prior to marketing in the United States. This chapter presents the key general chapters of the USP and the guidance documents of the FDA that allow drug product development in a manner sufficient to navigate the regulatory review and approval process.
