title: The FDA Maze.
abstract: 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.
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic; D003879:Dermatologic Agents / Q000494:pharmacology / Q000633:toxicity; D004341:Drug Evaluation; D004353:Drug Evaluation, Preclinical / Q000191:economics / Q000379:methods; D006801:Humans; D007880:Legislation, Drug; D010600:Pharmacology; D012098:Reproduction / Q000187:drug effects; D012106:Research; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D003879:Dermatologic Agents