FDA again re­quests com­ments on ni­trosamine im­pu­ri­ties in drugs

As the phar­ma in­dus­try con­tin­ues to grap­ple with the iden­ti­fi­ca­tion and con­trol of im­pu­ri­ties known as ni­trosamines in drugs, the FDA is once again seek­ing com­ment on how best to deal with these po­ten­tial­ly can­cer-caus­ing sub­stances.

The reg­u­la­tor is main­ly look­ing for new ideas to help con­trol the im­pu­ri­ties, not­ing in an 18-page Fed­er­al Reg­is­ter no­tice that the in­ves­ti­ga­tions in­to ni­trosamines in food and drugs have been around since 2018.

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