Revised Final Guidance on Nitrosamines Offers New Recommendations for Assessment and Control
FDA Law Blog
SEPTEMBER 11, 2024
For example, depending on the manufacturing process for a specific human drug, the use of some specific solvents, reagents, and catalysts may trigger the formation of these possible carcinogens. First, firms should undertake risk assessments of their APIs, finished products, and products under approved or pending applications.
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