US FDA Gives Industry An Extension On Nitrosamine Risk Assessments

The US Food and Drug Administration has agreed to giving manufacturers a one-month extension to review and test their medicines for the presence of nitrosamine impurities. Manufacturers will now have until March 31 to conduct these risk assessments. The original deadline was March 1.

The agency’s action responds to industry requests for more time to conduct the risk assessments. Perrigo Company PLC says that internal sites have been affected by stay-at-home orders issued due to the pandemic, and that such actions are limiting tests and risk assessments