Medical News & Perspectives
March 18, 1998

Implementing the FDA Modernization Act

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Copyright 1998 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.1998American Medical Association

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JAMA. 1998;279(11):815-816. doi:10.1001/jama.279.11.815

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.

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