Historical Case Studies of Drug Regulation

In this section you will find resources offering various perspectives on FDA's regulation of drugs throughout the agency's history.

Resources on the History of Drug Regulation

• Promoting Safe & Effective Drugs for 100 Years
• Sulfanilamide Disaster
• FDA and Clinical Drug Trials: A Short History
• FDA's Approval of the First Oral Contraceptive, Enovid
• Celebrating a Milestone: FDA's Approval of the First Genetically-Engineered Product
• "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