What is meant by “Required Under: Pediatric Research Equity Act” in the search results display?
On December 3, 2003, President Bush signed the Pediatric Research Equity Act (PREA) of 2003 to improve the quality of pediatric information in drug labeling, PREA was reauthorized on September 27, 2007. This legislation provides FDA with explicit authority to require applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration to include pediatric studies or clinical trials. The legislation also authorizes FDA to require pediatric studies or clinical trials of marketed drugs that are not adequately labeled for children after other opportunities to obtain such studies or clinical trials on a voluntary basis have been exhausted. The requirement for such studies or clinical trials may be waived if necessary studies or clinical trials in children are impossible, there is strong evidence suggesting the drug will not be effective or safe in children, the drug does not represent a meaningful therapeutic benefit over existing
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