FDA con­sol­i­dates non­clin­i­cal im­muno­tox­i­c­i­ty eval­u­a­tion guid­ance

The FDA on Wednes­day is­sued a new draft guid­ance con­sol­i­dat­ing its rec­om­men­da­tions on non­clin­i­cal safe­ty eval­u­a­tions for im­muno­tox­i­c­i­ty and with­drew an ear­li­er 2002 guid­ance on the top­ic.

The FDA says the guid­ance ad­dress­es is­sues re­lat­ed to eval­u­at­ing im­muno­tox­i­c­i­ty in­clud­ing im­mune sup­pres­sion, mod­u­la­tion and stim­u­la­tion and pro­vides rec­om­men­da­tions for car­cino­genic­i­ty as­sess­ments, der­mal sen­si­ti­za­tion, ad­ju­vant­ed vac­cine de­vel­op­ment and de­vel­op­men­tal and ju­ve­nile an­i­mal stud­ies.

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