Business · 03/09/2020
Control of Nitrosamine Impurities in Human Drugs; Guidance for Industry; Availability
The Food and Drug Administration has released a final guidance for industry on controlling nitrosamine impurities in human drugs, following recent unexpected findings of these impurities in certain medications. The guidance outlines steps manufacturers should take to detect and prevent nitrosamine impurities in pharmaceutical products.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →