On 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.
Tags
FDA’s final rule on LDTs: what does it mean for clinical laboratories?
On 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.
Rescheduling a Schedule I substance, and the Delta-8 controversy
Did you know that in the US, drugs and other chemicals are classified into 5 distinct categories depending on the drug’s acceptable medical use and its potential for abuse or dependency? Drugs federally classified as Schedule I substances by the US Drug Enforcement Administration (DEA) are considered to have the highest potential for abuse and for creating severe psychological and/or physical dependence. In addition to heroin, LSD and MDMA (ecstasy), cannabis is classified as a Schedule I substance in the Controlled Substance Act of 1970, which means it has no approved medical usage.
Thailand cannabis legalization
Thailand has become the first southeast Asian country to legalize cannabis for medical use. Cannabis was originally introduced into Thailand from India, and until it was outlawed in the 1930s, it was historically used as a kitchen condiment, medicine and source of fiber.
Breaking down the SCIEX Triple Quad™ 7500 LC-MS/MS System – QTRAP® Ready
Sensitivity and robustness carry different meanings in the world of mass spectrometry. Generally, sensitivity refers to an instrument’s ability to achieve lower limits of detection (LOD). Robustness, on the other hand, refers to an instrument’s ability to consistently...
SCIEX and Phenomenex on environmental and water quality analysis
Key workflows covered include: Pesticides, pharmaceuticals and personal care products (PPCPs) Polar pesticides, including...
A rising star in food allergen research: proteomics of shellfish allergen
It’s important to know what you’re eating, especially if you suffer from a food allergy.
About 220 million people worldwide live with a food allergy.1 These numbers, along with the complexity and severity of conditions, continue to rise. In America, there are about 32 million food allergy sufferers—5.6 million of those are children under the age of 18.2.2 That’s 1 out of every 13 children, or about 2 in every classroom. From a financial perspective, the cost of food allergy childcare for US families is up to $25 billion
No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.