OFFICE OF NEW DRUGS MODULE

Introduction

FDA's Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER) regulates pediatric drug development.

During the last century, laws were passed regarding the marketing of safe and effective human drugs, and some of the key legislation passed during this time was instrumental in addressing adverse events in children. Prior to passage of the Pure Food and Drug Act in 1906, there were two major examples of drug products that had very unfortunate consequences for children.