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FDA worried about pediatric drug labeling

The Food & Drug Administration (FDA) continues its effort to ensure that drug labels contain sufficient information about use for children. In December '94, FDA required manufacturers to determine if the pediatric use sections of labeling could be modified "based on adequate and well-controlled studies in adults and other supporting information." Companies would then submit a supplemental pediatric application where appropriate.
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FILED IN:  Machinery  > Labeling

But FDA says response from the pharmaceutical industry is underwhelming even after the agency extended the deadline for supplemental applications to April 6 1997. In November FDA sent a letter to 250 manufacturers asking whether and when companies intended to file supplements. FDA received only 40 responses by December. FDA said the absence of adequate pediatric labeling "continues to present a significant health issue" and added that the level of response to the 1994 final rule is a cause for concern.


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