The FDA and Drug Registration

The procedure for registering new prescription drug products in the United States is often considered the most rigorous in the world. It is a complex process involving vast amounts of time, money an people. At the core of this process is the United States Food and Drug Administration, known more simply as the FDA, or the Agency. This practical reference reviews the formal process for the registration of prescription drugs in the United States and briefly summarises the history of the FDA, along with relevant drug law that has influenced its development. It also compares the US registration process with other principal pharmaceutical markets, particularly the emerging European Union and certain other European national authorities. It concludes with some suggestions for an 'ideal' drug registration agency. Professionals in the pharmaceutical industry in all sectors and at all levels will find this an indispensible guide to the FDA and drug registration in the United States.