Selecting an LC-MS system for quantitation of pharmaceutical drug development by Kirsten Craven | 0 CommentsWe understand you are busy, needing to prioritize running instruments, reporting results and managing your laboratory to meet deadlines. We created a solution guide to explain how SCIEX systems fit in the drug development pipeline to save you time evaluating options.
FDA’s final rule on LDTs: what does it mean for clinical laboratories? by Pierre Negri | 0 CommentsOn April 29, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule regulating laboratory developed tests (LDTs) as in vitro diagnostic devices (IVDs) under the Federal Food, Drug and Cosmetic Act (FD&C Act). This rule amends FDA’s regulations to state that in vitro diagnostic tests “manufactured” by clinical laboratories fall within the scope of the FDA regulatory oversight and is poised to dramatically shift the way clinical diagnostic laboratories in the United States develop and offer LDTs in the future. Read this blog post for a basic overview of the scope, intent and implications of this final rule, including the regulatory requirements, exceptions and timeline for implementation.
Easing the demands of a compliant pharmaceutical laboratory by Kirsten Craven | 0 CommentsAt SCIEX, we are proud to provide analytical systems to the pharmaceutical industry. We work hard to understand the demands of analytical work and the processes required to develop and manufacture drugs.
Selecting an LC-MS system for quantitation of pharmaceutical drug development by Kirsten Craven | Blogs, Echo MS, Pharma, QTRAP / Triple Quad, ZenoTOF 7600 systemWe understand you are busy, needing to prioritize running instruments, reporting results and managing your laboratory to meet deadlines. We created a solution guide to explain how SCIEX systems fit in the drug development pipeline to save you time evaluating options.
FDA’s final rule on LDTs: what does it mean for clinical laboratories? by Pierre Negri | Blogs, ClinicalOn April 29, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule regulating laboratory developed tests (LDTs) as in vitro diagnostic devices (IVDs) under the Federal Food, Drug and Cosmetic Act (FD&C Act). This rule amends FDA’s regulations to state that in vitro diagnostic tests “manufactured” by clinical laboratories fall within the scope of the FDA regulatory oversight and is poised to dramatically shift the way clinical diagnostic laboratories in the United States develop and offer LDTs in the future. Read this blog post for a basic overview of the scope, intent and implications of this final rule, including the regulatory requirements, exceptions and timeline for implementation.
Easing the demands of a compliant pharmaceutical laboratory by Kirsten Craven | Blogs, Pharma, QTRAP / Triple Quad, ZenoTOF 7600 systemAt SCIEX, we are proud to provide analytical systems to the pharmaceutical industry. We work hard to understand the demands of analytical work and the processes required to develop and manufacture drugs.