ABSTRACT
Allergen vaccines and other biologics were first regulated by the Hygienic Laboratory of the Public Health and Marine Hospital Service. In 1930, the Hygienic Laboratory was renamed the National Institute (singular) of Health (NIH). The NIH continued to regulate biologics (beginning in 1955, through its Division of Biologics Standards) for over 40 years. In 1972, regulatory authority over biologics was transferred 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; five years later, the entities that regulated drugs and biologics were once again separated, and the Center for Biologics Evaluation and Research (CBER) assumed responsibility for allergenics regulation (1,2).
