Rx Labeling Final Rule Largely In Line With Draft Version
This article was originally published in The Pink Sheet Daily
New labeling format will apply initially to recently approved drugs and products receiving approval for new uses, agency says.
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Product labels can be required to have warnings related to commonly prescribed unapproved uses with significant safety risks.
Final regulation eliminates use of letter-based categories to designate level of risk during pregnancy and lactation; in a change from the 2008 proposed rule, information relevant to drug effects on reproductive potential will now be housed in dedicated section.
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.