© 2004 by Oxford University Press
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© 2004 Oxford University Press
NEWS |
Pediatric Research Equity Act
The Pediatric Research Equity Act, passed by Congress in 2003, gave the U.S. Food and Drug Administration the authority to require drug manufacturers to perform pediatric testing on certain products.In October of 2002, a U.S. district court ruled that the FDA lacked sufficient statutory authority to require pediatric studies and prevented FDA from enforcing the requirements that were originally mandated in a 1998 regulation known as the "pediatric rule." After the court ruling, the FDA sought a congressional mandate that would give the agency the authority to require such studies.
The full text of the act is available at http://www.fda.gov/opacom/laws/prea.html.
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J Natl Cancer Inst 2004 96: 1808-1810.
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