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NLM History of Medicine Division Releases Digital Archive of FDA Court Cases

The Archives and Modern Manuscripts Program at the History of Medicine Division, National Library of Medicine is pleased to announce the release of a new digital archive of court case summaries published as the Food and Drugs Act Notices of Judgment (http://archive.nlm.nih.gov/fdanj/).

The collection is a digital archive of the notices judgment for products seized under authority of the 1906 Pure Food and Drug Act and the 1938 Food, Drug, and Cosmetic Act. The NJs are resources in themselves, but also lead users to the over 2,000 linear foot collection of the evidence files used to prosecute each case. These files include materials such as correspondence, lab results, photographs, and product samples and labeling. This collection offers insight into U.S. legal and governmental history, as well as the evolution of clinical trial science and the social impact of medicine on health. The legal history of some of our best-known consumer items of today, such as Coca Cola, and companies like Merck Pharmaceuticals, can be traced in the collection.

Users can perform full-text searching and browse the archive by Case Title, Defendant Name, Adjudicating Court Name, Geographic Seizure Location, and Case Publication Date.

To preserve these NJs and make them accessible, we have created a digital archive of both page images and metadata for each NJ. The archive was developed as a joint research project between HMD and the Lister Hill Center's Communications Engineering Branch (CEB). CEB's System for Preservation of Electronic Resources (SPER) is a set of Java-based applications currently used in conjunction with the DSpace platform. Among other archiving and preservation functions, SPER performs automated metadata extraction (AME) from TIFF page images, quality control review, and batch ingest of objects in an integrated fashion. SPER leverages the powerful archiving infrastructure and access mechanisms provided by DSpace for storage and dissemination, but the operations are modularized so that they can be used as standalone services or integrated with other repository or digital archive platforms or web services.

The current content consists of over 6,800 cases (over 4,300 pages) covering actions against Drugs and Devices from 1940-1963. As we complete work on other portions of the collection they will be released on an ongoing basis. Users are welcome to visit the library to use the hard copies at any time.

Future releases:

  • Foods and Drugs, 1908-1943 (31,000 cases/21,000 pages)
  • Foods, 1940-1966 (30,000 cases/9,800 pages)
  • Cosmetics, 1940-1964 (256 cases)

For more information, please contact John P. Rees, Curator, Archives and Modern Manuscripts Program, at reesj@mail.nlm.nih.gov

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