OFFICE OF NEW DRUGS MODULE

Learning Objectives

Upon completion of the Pediatric Regulations unit, you will be able to:

• Discuss the events leading to the regulation of pediatric drugs
• Describe the changes that have taken place over the last century in pediatric drug development
• Characterize the age cohorts with respect to pediatric drug studies
• Describe the different types of pediatric drug legislation
• Compare the attributes of the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA)

Now that you understand the objectives we are trying to achieve, let's begin this unit.