Answers to Questions on Selected FDA Bureau of Biologics' Regulation Activities

HRD-80-55: Published: Jun 6, 1980. Publicly Released: Jun 6, 1980.

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The efforts of the Food and Drug Administration (FDA), Bureau of Biologics to regulate vaccines and allergenic products were examined.

The review was made in accordance with the provisions of the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. Results of the review showed that the Bureau was limited by: (1) a relatively weak science base for understanding these products; (2) problems in conducting adequate and well-controlled clinical investigations on these products; and (3) the large number of products on the market.

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