Accelerating INDs Without Animals: How CROs Can Capitalize on FDA’s New Methodologies
A landmark FDA direct final rule officially clears the path for organs-on-chips and in vitro models. Advanced CROs can capture the shifting outsourcing market
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Legal and Regulatory Articles
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Advancing Lyme Disease Treatment: FDA Guidance for Drug Development
Discover how new FDA guidelines shape Lyme disease drug development and impact clinical care for early erythema migrans cases
Cleaning Validation: Regulatory Expectations and Methodologies
Ensure product safety and regulatory compliance. Discover essential cleaning validation strategies and methodologies for your laboratory operations
Tackling FDA Import Detentions with Third-Party Lab Testing
How partnering with accredited contract labs can provide the critical testing and documentation needed to overcome FDA import detentions and get your products to market
FDA Approves ELISA Companion Diagnostic
A comprehensive solution for precise concizumab-mtci monitoring in hemophilia patients
ASK THE LAB EXPERT: Promoting User-First Lab Automation with AI-Powered Innovations
Wael Zebdeh discusses how AI is reshaping laboratories and ensuring “quality, speed, and compliance coexist seamlessly”
Navigating Compliance and Regulatory Standards with LIMS
How modern LIMS streamlines lab compliance with international standards
2025 Laboratory Quality & Compliance Week Webinars Available On Demand Now
Watch your favorite or all the webinars from the virtual event on demand for free
SQF Certification: A Trusted Standard for Farm-to-Fork Food Safety
Whether you're growing produce, packaging frozen meals, or operating a logistics hub, SQF certification offers a pathway to safer products, better operations, and greater market reach.
Laboratory-Developed Tests: Recent Regulatory Changes and Industry Effects
Evolving FDA regulations and legal rulings affecting LDTs have impacted clinical and contract labs—a recent development may change the course
Laboratory Quality & Compliance Week: Simplifying Data Governance
Tracy Hibbs' session covers key elements of data governance, vigilant monitoring, and quality management
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