Meeting an Unprecedented Surge in Demand for Kit Production

Supply chain disruptions and manufacturing shortages have significantly affected the clinical trial industry, an issue exacerbated by an unprecedented demand for clinical trial kits. To help maintain business continuity, the Labcorp Central Laboratories team had to develop creative operational solutions at every step of production and quickly accelerate the launch of their new automated kit production facility in Europe.

Uncovering the Regulatory Advice Affecting OECD 443 Study Design and the Impact on Your Ongoing and Future Studies

The Extended One Generation Reproductive Toxicity Study (EOGRTS, EU B.56, OECD TG 443) has been the information requirement for reproductive toxicity under the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH, Annexes IX and X, Section 8.7.3.) since March 2015.

Cell and Gene Therapy Answers: Advancing treatments for pediatric patients with rare diseases

Labcorp’s cell and gene therapy scientific leaders shared their insights on the factors that make rare and pediatric diseases a good fit for cell and gene therapy, along with the key challenges and best practices in this innovative space.

Cell and gene therapy answers: Overcoming challenges for rare disease in pediatrics

Your source for answers to the complex challenges of cell and gene therapy development.

Three healthy habits to fight cardiovascular disease

February is American Heart Month and, perhaps more famously, home to Valentine’s Day. This makes it an ideal time for you to start loving your heart.

Improving diagnostic efficiencies in histology with artificial intelligence and digital scoring

Digital analysis and artificial intelligence (AI) are not novel in anatomic pathology and histology, but the technology continues to evolve as it supports clinical trial enrollment as well as routine work in pathology.

Optimizing success in application for US EPA registration of conventional new plant protection active substances under FIFRA

To open up the US crop protection market for an active substance you have already registered elsewhere, you will need to compare your existing data against the regulatory requirements of the US Environmental Protection Agency (EPA). In this blog, we outline the US regulatory landscape and suggest ways of optimizing registration success within it.

Rare Disease Day 2022: Supporting patients, celebrating advancements

February 28 is Rare Disease Day, a day dear to the hearts of many at Labcorp. The day is observed to raise awareness and give support to the more than 300 million people worldwide living with rare diseases, as well as their family members and caretakers.

TSCA and US state legislation: Navigating your chemical or agrochemical through the federal and state regulatory landscape in the USA

Registering your chemical or crop protection product with the US EPA under TSCA or FIFRA is the first and biggest step in its regulatory journey in the USA. But you will also need to navigate state-specific legislation and regulations, and for crop chemicals this includes registering in every state where they will be used.

Advancing inhalation toxicology capabilities to support chemical testing

Respiratory exposure to chemicals or agrochemicals poses potential risk to human health, especially to workers handling these products. Whether preparing a solution, dusting or spraying crops, or cleaning equipment, opportunities for inadvertent inhalation is a risk that can potentially lead to toxic effects, both acute and chronic. That’s why identifying potential risk posed by respiratory exposure to a chemical or agrochemical is a mandatory component of toxicology studies in regulatory submissions for new registrations and, often, for re-registrations. In addition to the requirement, inhalation studies themselves are complex and challenging, as delivery of test articles via the inhalation route requires careful attention to substance aerosolization and particle size as well as constant control and monitoring over a prolonged time.