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Charles Marwick

JAMA. 1998;279:815-816.

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

THE FOOD AND DRUG Administration (FDA) intends to proceed as quickly as possible to implement legislation passed by Congress last year. Described as "the most important change in drug regulation in 20 years" by Sharon Smith Holston, deputy commissioner for external affairs, the law, known formally as the FDA Modernization Act of 1997, is expected to have a significant impact on the health care community.

Holston cited requirements for changes in drug label information, development of a clinical trial database, improved patient access to drugs, and new consideration of pharmacy compounding among the principal provisions.

A measure of the extent of the task is that implementation of the act will require 42 new regulations, most of which must be issued as proposals with time for comment before a final rule is published. There will have to be at least 23 new guidance notices, and 45 reports and other . . . [Full Text of this Article]

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