Sterility Testing: Ensuring Safety in Critical Industries
Ensuring product sterility is vital for patient safety, regulatory compliance, and quality assurance across pharmaceutical, medical device, and biotech sector
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Life Science and Medicine
CDRH Announces Intent to Initiate the Reclassification Process for Most High Risk IVDs
FOR IMMEDIATE RELEASEJanuary 31, 2024 The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH) As CDRH moves into 2024 and beyond, the Center intends to initiate the reclassification process for...
FDA and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They Are Made
In recent years, the FDA has identified several concerns with laboratory developed tests ( LFTs)
A Comprehensive Guide to AAMI Medical Device Testing
The Association for the Advancement of Medical Instrumentation (AAMI) is a leader in the development and promotion of standards for medical devices, helping ensure that these products meet safety, performance, and reliability criteria. AAMI medical device testing...
ASK THE LAB EXPERT: The Complex Nature of Drug Formulation: Stories from a Formulation Lab
Drug formulation is and continues to be challenging. Every product is different. Every drug behaves differently based on its physicochemical properties. Understanding those properties through preformulation and in vitro permeability testing is important in designing an appropriate dosage form.
Therapeutic Goods Administration (TGA): Ensuring the Safety and Quality of Therapeutic Products in Australia
The Therapeutic Goods Administration, or TGA is a division of the Australian Government Department of Health. The TGA is responsible for regulating therapeutic goods, like prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products.
The Importance of Pharmaceutical ADME Studies
Pharmaceutical ADME studies are designed to investigate how a chemical is processed by an organism.
The Vital Role of IgY Testing on Dried Egg Yolk for Dietary Supplements
We received this request yesterday at Contract Laboratories! Diet supplements are always a popular industry, but egg yolks are a unique testing medium! let's spotlight this test request and dig a little deeper into IgY assays.
CAM Assay: A Key Tool for Angiogenesis and Cancer Research
The CAM assay, or Chorioallantoic Membrane assay, is a technique in biological research that involves the using a developing chicken embryo for experimental purposes.
The Importance of Testing Canine Hip and Joint Supplements
Just like for human supplements, the role that laboratories play in testing dog hip and joint supplements is indispensable
Different Types of Antibodies: A Guide to IgG, IgM, and IgA
Explore the roles and importance of various antibodies such as IgG, IgM, and IgA in the human immune system, and how they protect the body from infections and diseases
Small and Large Molecules: Pharmaceutical Drug Development
Researchers, developers, and manufacturers must remain adept at utilizing both small and large molecule approaches, leveraging their unique advantages to address unmet medical needs.
What Does Turnaround Time (TAT) Mean?
Turnaround time is a crucial performance indicator in laboratory testing that directly impacts clinical decisions, patient outcomes, and healthcare efficiency.
FDA Warns Against Ovarian Cancer Screening Tests
False or inaccurate results may result in delayed treatments
Raise Awareness for Rare Diseases Research | R&D
Spread the Word to Increase Rare Disease Awareness and Research On Rare Disease Day, more than 27 countries will promote this day to increase awareness for rare diseases. Across the world, this will be a day dedicated to raising awareness for different rare...
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Editor's Choice
Chemical Safety Testing of School Supplies: Ensuring Crayons, Markers, and Glue Are Safe for Children
As children head back to school, parents, teachers, and caregivers focus on...
Food Safety Testing for Lunch Boxes and Food Storage Containers
As parents and guardians prepare their children for the new school year, one...
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