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FDAMA exclusivity provisions could be fulfilled by one pediatric clinical study -- NDMA.

This article was originally published in The Tan Sheet

Executive Summary

FDAMA EXCLUSIVITY FULFILLMENT WITH ONE PEDIATRIC CLINICAL STUDY is recommended by the Nonprescription Drug Manufacturers Association in April 15 comments to FDA on the draft list of approved drugs for which additional information may support health benefits in the pediatric population. "We believe that one adequately designed and well-controlled clinical study (as described above), or other clinical exposure in children not previously contemplated under FDA's prior rule, should be sufficient to fulfill the FDAMA exclusivity provisions on pediatric studies and that Rx and OTC drugs should be treated equally in this regard," NDMA maintains. "We ask FDA to affirm these points."

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