FDA analgesics alcohol warning proposal will urge voluntary compliance prior to rule.
This article was originally published in The Tan Sheet
FDA OTC ANALGESICS ALCOHOL WARNING PROPOSED RULE will require the warning for all monograph and NDAed nonprescription analgesics and will "encourage" manufacturers to "voluntarily" apply the warning to labels prior to the issue of a final rule. The agency discussed the upcoming proposal in a March 14 letter to the Nonprescription Drug Manufacturers Association.
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