The History of Drug Regulation

Federal regulation of drugs emerged as early as 1848, under a law that addressed only imported drugs. In 1905 the American Medical Association launched a private, voluntary means of controlling a substantial part of the drug marketplace, a system that remained in place for over a half-century. Drug regulation in FDA has evolved considerably since President Theodore Roosevelt signed the 1906 Pure Food and Drugs Act.

Resources on the History of Drug Regulation

• Promoting Safe & Effective Drugs for 100 Years
• Milestones of Drug Regulation in the United States
• Early Work of the Bureau of Chemistry Drug Lab
• Sulfanilamide Disaster
• FDA and Clinical Drug Trials: A Short History
• FDA's Approval of the First Oral Contraceptive, Enovid
• "God, Motherhood and the Flag": Implementing the First Pharmaceutical Current Good Manufacturing Practices (CGMPs) Regulations
• Statins: A Success Story Involving FDA, Academia and Industry
• Summary of NDA Approvals & Receipts, 1938 to the present

 

Resources on the History of the Center for Drug Evaluation and Research

• Center for Drug Evaluation and Research Brochure and Chronology
• A Brief History of the Center for Drug Evaluation and Research
• CDER History Slideshow 
• CDER Slide Show Quiz
• CDER Slide Show Answers Key