The FDA and Drug Registration

The procedure for registering new prescription drug products in the United States is considered the most rigorous in the world. Reviewing the formal process for the registration of prescription drugs in the United States, this reference summarizes 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 and concludes with suggestions for an ideal drug registration agency. Professionals in the pharmaceutical industry in all sectors and at all levels will find this an indispensable guide.