To ensure the safety of the U.S. drug supply, the guidance recommends that manufacturers should conclude the risk assessment of approved or marketed products, the first of three steps manufacturers should follow to mitigate nitrosamine impurities in their products, within 6 months of publication of the guidance. Through today’s revision to the guidance, FDA extends the recommended timeframe for completion of risk assessments to March 31, 2021.
Manufacturers do not need to submit risk assessment documents to the agency, but they should retain these documents so that they are available if requested....[FDA]
