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FDA Gets Advice on Modernization Act Compliance
Charles Marwick
JAMA. 1998;280:1214-1215.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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AS THE US Food and Drug Administration (FDA) prepares its plan describing how it intends to comply with the FDA Modernization Act, which must be published by the congressionally mandated deadline of November 21, 1998, it is seekiing advice from a variety of health professionals, pharmaceutical groups, and consumer organizations.
Advice From Those Who Know
Congress and FDA staff recognize that the groups directly involved are most able to help the agency develop a practicable and useful plan. To this end, the agency has been a holding a series of meetings seeking their advice. While some of the recommendations are technical, such as improving submission and reviewing procedures, many directly involve physicians and their patients.
Among the suggestions that have been put forward are:
- Take more aggressive steps to prevent medication errors.
- Improve postmarketing surveillance.
- Expand and tighten the current system for reporting adverse drug reactions.
- Develop a . . . [Full Text of this Article]
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