The FDA is get­ting its hands on a ‘hu­man em­u­la­tion sys­tem,’ and Em­u­late hopes they nev­er let go

The fu­ture for the or­gans-on-chips in­dus­try will de­pend to a large ex­tent on the FDA’s abil­i­ty to un­der­stand how it works as well as its prac­ti­cal, near-term po­ten­tial for re­plac­ing an­i­mals in pre­clin­i­cal re­search as the sys­tem evolves. And now reg­u­la­tors are about to get some hands-on ex­pe­ri­ence with a col­lab­o­ra­tive ef­fort to build a hu­man em­u­la­tion sys­tem in­side the agency.

The FDA has agreed to work with Em­u­late, a spin­off of the Wyss In­sti­tute which has been de­vel­op­ing and im­prov­ing on the in­dus­try stan­dard in the field, snag­ging part­ner­ships with the likes of Mer­ck and J&J. The work will be done un­der a Co­op­er­a­tive Re­search and De­vel­op­ment Agree­ment (CRA­DA), cre­at­ing a plat­form for tox test­ing for prod­ucts like foods, di­etary test­ing and cos­met­ics.

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