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Charles Marwick

JAMA. 1998;279:899-901.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

A NEW STORM is brewing over how to maintain effective and expeditious regulation of an ever-broadening spectrum of biological products, ranging from vaccines, allergens, blood, and diagnostic agents to a whole string of new biotechnologically derived agents. At stake is the capacity of the Food and Drug Administration (FDA) to protect the health of the public.

The paramount issue is safety. Unlike drugs that are used to treat existing illnesses, many biological products, such as vaccines, are used to prevent disease, and in some instances, such as childhood immunizations, their use is mandatory.

Another issue is the expeditious approval of products. At the heart of the matter is the proper role of research in fulfilling the FDA's mandate to license and approve safe and effective products. After a 25-year conflict on this issue, no resolution is in sight.

The responsibility for reviewing and licensing biological products falls on . . . [Full Text of this Article]

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