chapter  2
16 Pages

Modernizing the Food and Drug Administration

WithArthur Y. Tsien, Esq.

INTRODUCTION AND OVERVIEW In recent years, Congress has enacted and the president has signed into law a number of significant changes to the Federal Food, Drug, and Cosmetic Act (FDC Act) to modernize the Food and Drug Administration’s (FDA) regulation of drugs and biological products. This chapter summarizes the significant changes.