This collection contains articles, clippings, correspondence, biographical material, draft of a manuscript, notes, and a poster regarding the life and work of Frances Kelsey. This material was collected by Linda Lear for a potential biography on Frances Kelsey. These materials primarily document the thalidomide controversy and Kelsey’s role in preventing the drug on the United States market. The chronological files contain copies of articles and newspaper reports on Frances Kelsey as the key FDA investigator, her awards for service, and questions regarding stricter government drug regulations. Also included are a selection of speeches made by Kelsey regarding the government’s role in regulating new drugs. Of interest is an autobiographical reflection written by Kelsey which discusses in-depth her early life and education, her work at the University of Chicago and her work on the Sulfanilamide case, her work between graduate school and the FDA, and her experience regarding the thalidomide case.