Insights

For international manufacturers, seeking FDA approval can present many challenges. We have guidance to help you navigate the regulatory landscape and streamline your approval process.

CLSI is coming to AMP! See CLSI subject matter experts, engage with CLSI staff, and more.

World Standards Day is an annual celebration to pay tribute to the collaborative efforts of thousands of experts worldwide who develop the voluntary technical agreements that are published as international standards.

We spoke with Dr. Bradford Therrell, an expert in newborn screening and an author for CLSI NBS01 about the importance of newborn screening and it's global impact.

CLSI is excited to celebrate Dr. Michael Loeffelholz for receiving the 2026 ASM Service Award from the American Society of Microbiology.

The table provided maps specific Clinical and Laboratory Standards Institute (CLSI) Evaluation Protocol (EP) documents that cover the Verification Phase of the Test Life Phases Model to assist medical laboratories verifying performance claims for both laboratory-developed tests and regulatory cleared or approved test methods.

At Texas A&M University, veterinary students are introduced to antimicrobial susceptibility testing (AST) through the integration of CLSI VET09 into their curriculum, shaping the future of veterinarians and the patients they serve.

CLSI experts will be attending ADLM 2025 in Chicago, Illinois 27-31 July. Here's your guide to key talks you won't want to miss!

CLSI recently hosted it's June 2025 Committees Week in Frisco, Texas. Here are key highlights from the meetings.

If you missed us on April 29, Testing With Confidence: Evaluation Protocols and Strategies for Compliance, don’t worry. Here’s a recap of key panel discussions and how you can still get involved.