New FDA guidance gives manufacturers limits for nitrosamines

Af­ter as­sess­ing com­ments from in­dus­try play­ers, the FDA has fi­nal­ly is­sued its fi­nal guid­ance with rec­om­men­da­tions on ac­cept­able in­take lim­its for ni­trosamine im­pu­ri­ties in drugs.

The 24-page guid­ance pub­lished Fri­day delves in­to the top­ic of ni­trosamine drug sub­stance-re­lat­ed im­pu­ri­ties, or ND­SRIs, which can cause can­cer. And com­pa­nies have un­til Nov. 1 to com­plete some as­sess­ments, with the FDA ex­plain­ing:

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