FDA issued a warning to drug-device combination manufacturers about nitrosamine impurities that could increase the risk of ...
The US Food and Drug Administration (FDA) has released a draft guidance document aimed at setting impurity limits for ...
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
All aspects of a drug’s lifecycle should be considered when evaluating risk assessment for elemental impurities. The safety of a drug product is as important as its effectiveness. Testing a drug for ...
Our FDA Compliance & Enforcement Team reviews how the Food and Drug Administration’s first guidance on nitrosamine impurities shows what the FDA has learned about the sources of such impurities and ...
Nitrosamine impurities became a topic of focus when health regulators recalled valsartan, an antihypertensive drug, due to the presence of N-nitrosodimethylamine (NDMA), a probable carcinogenic agent ...
Febuxostat is a novel, non-purine, selective inhibitor of xanthine oxidase for hyperuricemia in patients with gout. It is the first promising substitute for allopurinol in 40 years. Various synthetic ...
From its initial development back in the 1950s, cell culture media development has been plagued by impurities, often present in small quantities, difficult to characterize, and trace back to their ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results