Chapter 7 - Postmarket surveillance and regulatory considerations in reproductive and developmental toxicology: an FDA perspective

Abstract

This chapter discusses postmarket surveillance and regulatory considerations in reproductive and developmental toxicology: an Food and Drug Administration (FDA) perspective. The US FDA is a regulatory, science-based federal agency responsible for protecting and promoting the public health through the monitoring and regulation of a number of items necessary for the health and wellbeing of consumers. The FDA is made up of six centers: Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Veterinary Medicine (CVM), Center for Food Safety and Nutrition (CFSAN), and Center for Tobacco Products (CTP). The safety of the medical products regulated by the FDA has been a key focus of the Agency since it was established more than a century ago as the nation's first consumer protection agency. Human drugs are approved and monitored by the FDA's CDER. CBER has the mission to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. The CVM is responsible for approving drugs for animals, including drugs used in medicated feeds, and for monitoring drugs and feeds intended for use in animals. The Veterinary Biologics Pharmacovigilance Program is for the ongoing surveillance of adverse events associated with animal vaccines and other biologics, in cooperation with the veterinary profession and the veterinary biologics industry.