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Overview of the US Food and Drug Administration's reform legislation
1Medicine Staff Office, US Food and Drug Administration, Rockville, Maryland 20857, USA.
Clinical Therapeutics
|January 23, 1999
Abstract:
This paper addresses the most commonly discussed issues regarding the US Food and Drug Administration Modernization Act. Particular emphasis is given to aspects that affect the pharmaceutical industry. It also discusses the agency's current efforts regarding implementation of specific provisions of the Act.