Manufacturers, industry groups comment on FDA’s control over nitrosamines in drug products

The FDA has re­ceived com­ments from man­u­fac­tur­ers and oth­er in­dus­try play­ers on how best to tack­le im­pu­ri­ties known as ni­trosamines in drugs.

In May, the FDA sought out com­ments from man­u­fac­tur­ers and oth­er stake­hold­ers on how best to deal with the po­ten­tial­ly can­cer-caus­ing sub­stances af­ter it pre­vi­ous­ly is­sued guid­ance. The reg­u­la­tor pub­lished the com­ments ear­li­er this month.

The FDA first be­gan in­ves­ti­gat­ing ni­trosamines in 2018 over con­cerns about im­pu­ri­ties in the blood-pres­sure drug val­sar­tan. It then put out guid­ance for man­u­fac­tur­ers in 2020 that re­quired them to con­duct risk as­sess­ments of all ap­proved or mar­ket­ed prod­ucts to de­tect po­ten­tial­ly can­cer-caus­ing ni­trosamine im­pu­ri­ties and en­sure that their prod­ucts have ac­cept­able lev­els of the im­pu­ri­ties.

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