ABSTRACT

The beginning of dermatoxicology can be dated to 1944, when the late John Draize introduced the Draize tests (1). A special issue of Toxicology and Applied Pharmacology has already reviewed some of the advances in this fi eld (2). We take the liberty here of reviewing dermatoxicologic drug related withdrawals in light of their history and the current knowledge of the underpinnings of the science and art of dermatoxicity as it relates to the adoption of new dermatologically oriented drugs. We focus on FDA withdrawals starting with the Kefauver Harris Amendment of 1962, which required drug sponsors to provide safety and effectiveness data before approval (3). Note that nonclinical and clinical evaluation of drugs has changed dramatically in the past 15 years-following increased dermatoxicologic knowledge.