Nitrosamine Contamination in Generics: Recent Cases and Regulatory Response
Martyn F. Feb. 7 0Nitrosamine contamination in generic drugs has triggered hundreds of recalls since 2018, exposing hidden cancer risks in everyday medications. The FDA's response has reshaped global drug safety standards - and forced manufacturers to rethink how medicines are made.
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Nitrosamine Contamination in Generics: Recent Cases and Regulatory Response
Martyn F. Feb. 7 0Since 2018, nitrosamine contamination has triggered hundreds of recalls in generic drugs like valsartan, metformin, and Zantac. Learn how these carcinogenic impurities form, why regulators changed their rules, and what it means for patients and manufacturers.
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Real-World Evidence Sources for Drug Safety: Registries and Claims Data Explained
Martyn F. Feb. 5 2How registries and claims data help monitor drug safety after approval. Learn about FDA's use of these sources, their strengths and limitations, and current innovations in drug safety monitoring.
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