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PREA draft guidance

This article was originally published in The Tan Sheet

Executive Summary

Recommendations on how to interpret the requirements of the Pediatric Research Equity Act are included in a FDL-1draft guidance published in the Federal Register Sept. 7. The Act, which became law in December 2003, requires studies to be conducted in drugs that will be frequently used by children to assure that the products bear adequate pediatric labeling. PREA does not impose study requirements on abbreviated new drug applications that do not propose a new indication, new dosage form or new route of administration, the draft guidance notes. The document also states that the type of data required for submission "will depend on the nature of the application [and] what is known about the product in pediatric populations." For example, pediatric effectiveness could be extrapolated from "adequate and well-controlled studies in adults" if the disease and its treatment are similar in adult and pediatric populations. Comments are due Nov. 7...





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