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Medical News & Perspectives
October 14, 1998

FDA Gets Advice on Modernization Act Compliance

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JAMA. 1998;280(14):1214-1215. doi:10.1001/jama.280.14.1214-JMN1014-3-1

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.

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.