This guide is designed to familiarize FDA staff, other government employees, historians, the press, regulated industry, students, and anyone else interested in regulatory history with the various resources on the history of the FDA. Included are both core sources useful for specific inquiries into the agency's past and information for those pursuing extensive historical research on the FDA. In addition, the guide discusses the structure, functions, and some of the programs of the FDA History Office. The office has a wide range of functions and offers various types of assistance to staff and outsiders, as reflected in some of the programs and activities mentioned at the end of this guide. The FDA is the oldest federal agency that has as its principal purpose the protection of consumer health; this guide will help those who want to learn more about the evolution of this agency.

While research is a primary function of the FDA History Office, we also try to facilitate studies by historians and others. Often a person needs merely a reference or two to investigate a particular question on the history of regulation and FDA, and History Office staff will run a quick check of our internal reference files to assist with such a query. However, some individuals have a much broader interest in FDA history, requiring more extensive research and resulting in lengthy articles and books. Some scholars devote entire careers to the study of FDA and related history. The resources available for the study of this subject are extensive, and here we can indicate only some of the more basic places to begin. The majority of the published secondary sources should be easily obtainable at most university libraries, but many of the published primary sources would more likely be found in law libraries, general university libraries, or other facilities designated as government document depository libraries. If uncertain, check with a reference librarian. Locations of the unpublished records are mentioned below.