Perspective: Convergence of CLIA and FDA Requirements: A Rationale Shift in the Regulatory Paradigm

The laboratory developed test (LDT) has proven to be a flexible, quick, lower-investment assay commercialization option—yet the evolving regulatory landscape still threatens to alter that. How can you navigate these tougher requirements while maximizing efficiencies? This brief will help you plan and prepare, ensuring that your quality systems and validation studies support FDA and CLIA requirements as they evolve—and that you stay a step ahead of regulatory demands.

Get the brief

    Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.