Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 79

Since the time of the shoguns, multiple other government authorities have become involved in drug safety. Very often governments have responded to misbehavior or tragedies by strengthening laws intended to address perceived shortcomings in protecting patient safety. In the past 30 or so years, the number of organizations devoted to drug safety has increased markedly, in particular, outside the United States. This chapter is focused on key activities of the US Food and Drug Administration (FDA), which regulates biopharmaceutical products and medical devices for human use. FDA also regulates certain foods and veterinary products, for a total of more than US$ 2.4 trillion worth of products each year. The latter topics are outside the scope of this chapter.

The FDA is a complex organization with over 15,000 employees strategically posted at US domestic locations and overseas stations. Several distinct parts of FDA handle safety matters. The largest areas touching drug safety reside within the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). In addition, within CDER and CBER, functions are generally split between pre- and post-marketing regulatory activities.

The FDA has undergone and continues to undergo major changes following various scientific, public, and political controversies, drug withdrawals, investigations, and changes in the law. This chapter will summarize the key functions that deal with medical product safety and will outline some of the initiatives that will undoubtedly lead to further advances in “regulatory science” in the coming years.