Drugs con­tain­ing nano­ma­te­ri­als: FDA fi­nal­izes 2017 guid­ance with sev­er­al changes

The FDA on Thurs­day fi­nal­ized a draft guid­ance from 2017 ex­plain­ing the prin­ci­ples and spe­cif­ic con­sid­er­a­tions for de­vel­op­ing drugs (bi­o­log­ics and gene ther­a­pies are ex­clud­ed) con­tain­ing nano­ma­te­ri­als, in­clud­ing via ab­bre­vi­at­ed path­ways.

Con­sid­er­a­tions re­lat­ed to qual­i­ty, non­clin­i­cal, and clin­i­cal stud­ies are in­clud­ed in the 29-page fi­nal guid­ance, which al­so fea­tures “two note­wor­thy changes” from the draft ver­sion in re­sponse to stake­hold­er com­ments, ac­cord­ing to the FDA.

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