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US FDA Gives Industry An Extension On Nitrosamine Risk Assessments

 
• By Joanne S. Eglovitch

Drug makers win one-month reprieve for their nitrosamine risk assessments for new drug products and approved products.

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Industry Gets Small Deadline Reprieve For Nitrosamine Risk Assessments • Source: Shutterstock

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.

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