FDA’s Nonclinical Testing Rule: What It Means for CROs Offering NAMs
US FDA's direct final rule rewrites drug and biologics regulations to cover in vitro, in silico, and organ-chip studies, giving NAM-ready CROs a clearer opening with sponsors
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US FDA's direct final rule rewrites drug and biologics regulations to cover in vitro, in silico, and organ-chip studies, giving NAM-ready CROs a clearer opening with sponsors
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Ensuring Quality and Efficacy for Ozempic and Wegovy
Explore the primary diagnostic categories, the four-stage validation process, and the requirements for specialized lab testing
Learn the phases, STAT vs. routine benchmarks, what affects TAT in contract testing, and how to specify TAT requirements when outsourcing lab work
A breakdown of the exact laboratory methods used to validate green materials and ethical sourcing
From PFAS to supply chain compliance, 2025 tested how contract laboratories really adapted
The path toward a clinically useful ovarian cancer early detection test lies in the development of sophisticated, multi-modal screening strategies.
Cell and gene therapy are similar fields of biomedical research aimed at treating genetic diseases and are often combined in treatment.
CLIA inspections and evaluations assess a laboratory’s performance, record-keeping practices, and quality assurance protocols
Stay ahead with data-intensive, digitally connected, and regulation-driven clinical testing lab operations
Labs are under pressure to deliver results that are not only accurate but also traceable, defensible, and structured for global compliance.
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