The History of Biologics Regulation
Modern federal oversight of biological products began under the 1902 Biologics Control Act, which the Hygienic Laboratory of the Public Health and Marine Hospital Service carried out. With the creation of the National Institutes of Health from the Hygienic Laboratory, regulatory authority remained at NIH until 1972, when it was transferred to FDA.
In 2002, the Center for Biologics Evaluation and Research celebrated the centennial anniversary of the 1902 Biologics Control Act. The following materials were created to commemorate the past 100 years of the regulation of biological products:
Resources on the History of Biological Product Regulation
- The Road to the Biotech Revolution: Highlights of 100 Years of Biologics Regulation
- Biologics Centennial: 100 Years of Biologics Regulation
- Safety For Millions: The Biologics Control Act of 1902 Centennial
- Science and the Regulation of Biological Products
- Science and the Regulation of Biological Products (PDF)
Public Symposium Commemorating 100 Years of Biologics Regulation
- Symposium Agenda, 100 Years of Biologics Control 2002
- CBER Centennial Opening Presentation
- New Efforts in Counter-terrorism (100 Years of Biologics Symposium)
- Issues in Therapeutic Research (100 Years of Biologics Symposium)