Enforcing A Belated Chemistry Lesson – The Nitrosamines In Sartans Saga
How authorities plan to root out the carcinogenic impurities and what it means for other classes of medicines.
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US FDA Expands KASA Platform To Probe API Synthesis, Conduct NDA Quality Reviews
Agency builds on success with last year’s KASA-based ANDA quality reviews to widen and deepen the software tool’s functionality, says CDER OPQ leadership. CMC assessors are adapting quickly to a platform that could soon alert them to issues like possible genotoxic impurity formation during API synthesis.
Why The US FDA Did Not Appreciate Valisure’s Extra Measure Of Protection From Poor Quality Drugs
Unusual citations for DSCSA violations in a recent inspection report and untitled letter from the FDA provide insight into the agency's concerns about the pharmacy that second-guesses the regulatory system it oversees by testing drugs before dispensing them.
US FDA Sets Out Nitrosamines Guidance
Agency guidance establishes process for ridding unsafe levels of the probable carcinogens from the pharmaceutical supply chain.