ABSTRACT
I. INTRODUCTION Allergen extracts and other biological agents were first regulated in 1902 by the Hygienic Laboratory of the Public Health and Marine Hospital Service, renamed the National Institute (singular) of Health (NIH) in 1930. The NIH continued to regulate biologics from 1955 to 1972 through its Division of Biologics Standards. Regulatory authority over biologics was transferred in 1972 to the Bureau of Biologics at the Food and Drug Administration (FDA). In 1982, the FDA merged the Bureau of Biologics and the Bureau of Drugs into a single Center for Drugs and Biologics and 5 years later separated the entities that regulated drugs and biologics again, and the Center for Biologics Evaluation and Research (CBER) assumed responsibility for allergenics regulation (1,2).
