The FDA Maze
Levy, J.
Cutis 29(1): 54-60
1982
ISSN/ISBN: 0011-4162 PMID: 7035076 Document Number: 194513
The testing of new dermatologic pharmaceutical formulations is a long and expensive process. The subsequent regulatory submissions to the Food and Drug Administration (FDA) involve considerable detail and negotiations. Most dermatologists have only a superficial knowledge of the processes involved in proving the safety and efficacy of new drugs. This article is an attempt to impart a greater understanding of the procedures involved in obtaining FDA approval of new pharmaceutical entities.