FDA

Clostridium Testing in Food: Ensuring Safety and Quality through Accurate Detection

By Swathi Kodaikal | May 5, 2025

Effective clostridium testing is integral to food safety management, ensuring products are safe for consumption

Closeup of blue, rod-shaped bacteria on a red backgeround.

Dissolution Testing of Pharmaceuticals: Techniques, Equipment, and Regulatory Standards

By Trevor Henderson | May 1, 2025

As regulatory bodies like the FDA and USP continue to emphasize method validation and bioequivalence, laboratories must ensure their dissolution testing practices are scientifically sound and regulatory compliant.

image of tablet dissolving in water next to 2 tablets on a blue background illustrating the importance of dissolution testing in pharmaceutical development

Laboratory-Developed Tests: Recent Regulatory Changes and Industry Effects

By Swathi Kodaikal | Apr 10, 2025

Evolving FDA regulations and legal rulings affecting LDTs have impacted clinical and contract labs—a recent development may change the course

A female researcher wearing lab coat and gloves working in a laboratory setting.

Audit Preparedness for Contract Labs and Testing Facilities: A Guide to Ensuring Compliance and Confidence

By Swathi Kodaikal | Mar 25, 2025

Proactive audit preparedness is pivotal to ensure third-party laboratories stay compliant, reliable, and competent in the TIC space

A female researcher in lab coat and gloves examines a series of laboratory instruments.

Vici Health Sciences Joins the Contract Laboratory Network!

By Swathi Kodaikal | Mar 19, 2025

This CDMO specializes in new chemical entity (NCE) molecule, NDA 505(b)(2), and ANDA development programs

Welcoming BioTools Inc., to the Contract Laboratory Network

By Swathi Kodaikal | Mar 6, 2025

Their product offerings include instrumentation, specialized CRO services, and unique software and accessories

Laboratory Quality and Compliance Week: FDA Warning Letter Trends for Testing Labs

By Editorial Team | Feb 19, 2025

Dr Constance Y. Fears, one of the speakers at our upcoming virtual event, discuses her career as a drug investigator and the FDA 483 Warning Letter trends

Welcoming Portrett Pharmaceuticals to the Contract Laboratory Network

By Swathi Kodaikal | Jan 31, 2025

This CRO delivers FDA ready, cGMP-compliant analytical solutions quickly to keep drug development programs on track

Welcoming Bioassay GmbH to the Contract Laboratory Network

By Swathi Kodaikal | Jan 24, 2025

They develop and perform GMP potency assays for a wide variety of drugs, proteins, monoclonal antibodies, vaccines and gene therapies

Environmental Microbiology in Water Testing: Everything You Need to Know

By Trevor Henderson | Jan 17, 2025

Environmental microbiology testing plays a critical role in assessing the safety and quality of water resources. Whether for drinking, industrial processes, agricultural irrigation, or recreational activities, water must be thoroughly monitored to ensure it is free...