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  5. Digital Primary Sources
  1. FDA History Research Tools

Digital Primary Sources

 

Below you will find links to various kinds of primary source documents relevant to FDA History.

FDA Notices of Judgment Collection -- For the first several decades of the Agency's existence, one of the primary enforcement actions available to the FDA was criminal prosecution.  When successful, these cases would result in a judgment in the Agency's favor, which the FDA would publish to promote public awareness of the court's findings.  The National Library of Medicine hosts a database of tens of thousands of Notices of Judgment that were issued against violative products from 1906 to 1964.

 

FDA Consumer Updates -- the FDA's official website lists a range of Consumer Updates to inform consumers about health risks.

 

FDA Press Releases  -- are posted on the FDA's official website, dating back three years.

 

Warning Letters -- the FDA's official website offers multiple methods to search warning letters issued to manufacturers, dating back to 2005.

 

Guidance to Industry -- the FDA's official website lists draft and final guidance documents on a broad range of issues.

 

Laws Enforced by FDA -- the agency's official website provides the text of major pieces of federal legislation that have established FDA's regulatory authorities.

 

Federal Register -- The FDA has been publishing notices in the Federal Register about agency activities, proposed rulemaking, legislative reforms and other policy changes since the FR first began publication in 1936.  The Library of Congress is in the process of digitizing historical issues of the Federal Register, which can be accessed on their website.  There are also private subscription services that provided digital database access to the full record of the Federal Register's publications.

 

FDA-USP Partners in Health -- the United States Pharmacopeia has assembled a brief overview of landmarks in its longstanding cooperative relationship with the FDA.  The website features several legislative texts and key court cases that had a formative influence on federal drug standards

 

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