Tags

  • Sorting

  • Filters

The honey sting

As a consumer it’s hard for me not to feel inundated with claims that our food is “all-natural” or “chemical-free” or that we should buy certain “superfoods” for their health benefits.  We read labels and trust that the product we are buying is what we are truly...

A new generation of therapeutic modalities

There are over 7,000 genetic diseases that could potentially be cured using gene therapy. Rare metabolic diseases, autoimmune disorders, cardiovascular disease and cancers are some of the top disease classes that can be addressed with gene therapies. With over 1,000...

Overcoming uncertainty in your PFAS analysis

Overcoming uncertainty in your PFAS analysis

Just like gum on the bottom of a shoe, the existence of per- and poly-fluorinated alkyl substances (PFAS) in our environment is a sticky one. If you’re in the field of environmental testing, then you’re all too familiar with the threat these substances have on public health. While we have learned a lot about them over the years, there is still much more to understand. With the right detection methods, we can gather the information we need to empower us to make informed decisions on reducing the risks they impose.

6 Signs it’s time for a new vendor

6 Signs it’s time for a new vendor

A lab’s success depends on many factors from instrument quality to efficient operations, including being partnered with the right vendor. A vendor is more than just a supplier. They should provide you with a high-level quality of support in maximizing the lifespan and performance of your systems, reducing downtime, enhancing ROI and more. How do you know if you’re partnered with the right one? Here are six signs it might be time to find someone new.

Nitrosamines: Where are we now?

Nitrosamines: Where are we now?

Nitrosamines are a large group of N-nitroso compounds that share a common functional N-N=O group. They are produced by a chemical reaction between a nitrosating agent and a secondary or tertiary amine. Back in 2018, nitrosamines suddenly found themselves in the spotlight when they were unexpectedly detected in medications for high blood pressure. Since then, they have been found in several other prescription medications, including those for heartburn, acid reflux and diabetes, resulting in manufacturers recalling some common medications.

FDA’s final rule on LDTs: what does it mean for clinical laboratories?

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.

Wordpress Social Share Plugin powered by Ultimatelysocial