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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