MAb therapeutic products and risk management

Abstract

The development of therapeutic antibodies, as well as therapeutics of other composition, is a time and resource intensive business. The process is highly regulated and the regulations change on a periodic basis. In the US, the Food and Drug Administration’s (FDA) procedures have been undergoing change every five years since 1992, when the Prescription Drug User Fee Act (PDUFA) was signed into law. This act must be reauthorized on a five-year basis, and so PDUFA was followed by the FDA Modernization Act of 1997, and, in 2002, reauthorization provisions were included in the Public Health Security and Bioterrorism Preparedness and Response Act. On September 27, 2007, the latest iteration, the FDA Amendments Act (FDAAA), was signed into law.