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Category: Regulatory Considerations

CMC Requirements for Cell and Gene Therapy for IND Applications

The U.S. Food and Drug Administration (FDA) has issued Chemistry, Manufacturing, and Control (CMC) recommendations for Investigational New Drug (IND) applications for human investigational gene…

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CLIA, COLA & CAP: What’s the Difference?

BioAgilytix’s CLIA Laboratory Director, Natalie Smith, outlines the differences between CLIA, CAP & COLA regulations & accreditations, and what they mean for laboratory testing quality.

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CLIA Requirements for Gene and Cell Therapy Programs

It's a common misconception that all aspects of cell & gene therapy research and development are excluded from CLIA oversight. We take a closer look…

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