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Volume 357:2217-2219 November 29, 2007 Number 22 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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The modern era of drug development began with the 1962 Kefauver-Harris Drug Amendments, which required that drugs be tested for efficacy as well as safety and gave the Food and Drug Administration (FDA) the authority to require sophisticated clinical trials before approving drugs.¹ Today, we can be confident that an approved drug will be effective for its labeled uses. The same cannot be said of the drug's safety. At the time of approval, a drug has typically been tested in several thousand patients, in studies powered to identify only relatively common adverse reactions. For example, a study that includes 3000 . . . [Full Text of this Article]

Source Information

Mr. Schultz is a partner at Zuckerman Spaeder LLP in Washington, DC, and a former deputy commissioner for policy at the Food and Drug Administration.

This article has been cited by other articles:

• Anderson, G. M., Juurlink, D., Detsky, A. S. (2008). Newly Approved Does Not Always Mean New and Improved. JAMA 299: 1598-1600 [Full Text]