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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