FDA’s Label Conversion Project Would Revise Data As Well As Reformat
This article was originally published in The Pink Sheet Daily
Solicitation asks for contractor to reformat labels to physician labeling rule format, including updates with new information from literature; generic companies like contractor, while brands say it will be resource-intensive for industry and FDA.
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Do drug labels try to serve too many masters? With no clear agreement on drug labels’ end user and FDA’s incomplete control of label content, the agency and its Pharmaceutical Science Advisory Committee struggle over how to convey drug-drug interaction information in labeling.
Agency is launching an initiative to encourage manufacturers exempt from the final rule to implement the labeling format change anyway; the rule does not apply to drugs approved before June 30, 2001, and only about 10% of brand products have the new format.
New labeling format will apply initially to recently approved drugs and products receiving approval for new uses, agency says.