THE PERVASIVELY REGULATED BUSINESS EXCEPTION AND THE FDA

 
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Wood, Valerie D.
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THE PERVASIVELY REGULATED BUSINESS EXCEPTION AND THE FDA (1995 Third Year Paper)
Abstract
Section 704 of the Federal Food, Drug and Cosmetic Act authorizes the Food and Drug Administration to conduct inspections of regulated business establishments. In the statute. Congress required that the inspections be at reasonable times and within reasonable limits and in a reasonable manner. Congress further restricted the inspections from including general financial and personnel data, and research data not relating to specially regulated drugs.
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http://nrs.harvard.edu/urn-3:HUL.InstRepos:8889438

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