US FDA Gives Industry An Extension On Nitrosamine Risk Assessments
Drug makers win one-month reprieve for their nitrosamine risk assessments for new drug products and approved products.
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Perrigo, Pfizer want the US FDA to postpone its March 1 deadline for conducting nitrosamine risk assessments. Generics exec cites“serious compliance challenges” in conducting these assessments due to difficulty in finding the right lab equipment necessary to quantify nitrosamine daily intake limits.
FDA officials say that process and supply chain risks are some of the root causes driving many of the nitrosamine contamination problems in recent months and manufacturers should work to contain and control these risks.
Agency guidance establishes process for ridding unsafe levels of the probable carcinogens from the pharmaceutical supply chain.