FDA finalizes opioid safety labeling changes

The FDA late Fri­day fi­nal­ized new re­quire­ments for safe­ty la­bel­ing on new opi­oid pain med­ica­tions, mark­ing progress in the agency’s ef­fort to crack down on opi­oid over­dos­es that have led to more than 100,000 deaths in the US an­nu­al­ly.

Fri­day’s ac­tion fol­lows up on a no­ti­fi­ca­tion the FDA sent in April di­rect­ing new and gener­ic drug ap­pli­ca­tion hold­ers to up­date their la­bels with in­for­ma­tion about the risk of over­dose and dos­ing rec­om­men­da­tions.

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