FDA launch­es pi­lot pro­gram in sup­port of com­plex tri­al de­signs for drugs and bi­o­log­ics

The FDA an­nounced a new pi­lot pro­gram Wednes­day aimed at en­cour­ag­ing the use of com­plex in­no­v­a­tive tri­al de­signs in the de­vel­op­ment of drugs and bi­o­log­ics.

Spon­sors se­lect­ed by the FDA based on the cri­te­ria for par­tic­i­pa­tion in the “Com­plex In­no­v­a­tive De­signs Pi­lot Meet­ing Pro­gram” will be able to en­gage staff in ear­ly dis­cus­sions on ap­proach­es to com­plex de­signs.

The pi­lot will re­main op­er­a­tional through 30 Sep­tem­ber 2022, but spon­sors have un­til 30 June 2022 to sub­mit meet­ing re­quests, ac­cord­ing to Wednes­day’s no­tice. Meet­ings un­der the pi­lot will be con­duct­ed by FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search or its Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search.

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