Abstract
The Food and Drug Administration has the responsibility of evaluating drugs to ensure that they are safe, effective, and properly labeled prior to marketing. This authority is derived from the Federal Food, Drug, and Cosmetic Act. The parent law was passed in 1906, and major revisions were made in 1938 and 1962. These congressional acts have followed notorious events. The 1906 act was influenced by Upton Sinclair’s book The Jungle, which drew public attention to the unsanitary conditions in the meat packing industry. The 1938 amendment followed a national tragedy in which over 100 persons died after ingesting a sulfanilamide elixir that contained diethylene glycol, a solvent used without any preliminary toxicological studies. The 1962 amendment, commonly known as the Kefauver-Harris Amendment, was triggered by the thalidomide incident, which caused a number of malformed babies and established that thalidomide was a fetotoxic agent.
This chapter is based on a presentation at the meeting of the American Association of Pharmaceutical Scientists, Washington, D.C., May 8, 1989.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
McKenzie AW, Stoughton RB. Method for comparing percutaneous absorption of steroids. Arch Dermatol. 1962;86:608–610.
Cornell RC, Stoughton RB. Correlation of the vasoconstrictor assay and clinical activity in psoriasis. Arch Dermatol. 1985;121:63–67.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 1993 Springer Science+Business Media New York
About this chapter
Cite this chapter
Evans, C.C. (1993). Ethical and Clinical Considerations for Topical Drug Products (Including Surgical Scrubs). In: Shah, V.P., Maibach, H.I. (eds) Topical Drug Bioavailability, Bioequivalence, and Penetration. Springer, Boston, MA. https://doi.org/10.1007/978-1-4899-1262-6_23
Download citation
DOI: https://doi.org/10.1007/978-1-4899-1262-6_23
Publisher Name: Springer, Boston, MA
Print ISBN: 978-1-4899-1264-0
Online ISBN: 978-1-4899-1262-6
eBook Packages: Springer Book Archive