Unapproved uses of approved drugs: FDA lays out pharma considerations for informing providers

The FDA on Mon­day pub­lished an­oth­er draft guid­ance on drug com­pa­nies’ com­mu­ni­ca­tions with health­care providers re­gard­ing the un­ap­proved use of ap­proved med­ical prod­ucts.

The 29-page guid­ance re­places a re­vised draft guid­ance from 2014, which laid out rec­om­mend­ed prac­tices for dis­trib­ut­ing sci­en­tif­ic and med­ical pub­li­ca­tions on un­ap­proved prod­ucts. The up­dat­ed ver­sion in­cludes a change in name, a new ques­tion and an­swer for­mat, and some changes to the scope of the guid­ance.

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