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Category: Regulatory Considerations

<a href="https://www.bioagilytix.com/blog/category/cmc-bioanalytical/">CMC Bioanalytical</a>

CMC Requirements for Cell and Gene Therapy for IND Applications

  • February 23, 2021

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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<a href="https://www.bioagilytix.com/blog/category/bioagilytix-insight/">BioAgilytix Insight</a>

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

  • August 19, 2020

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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<a href="https://www.bioagilytix.com/blog/category/cell-therapy/">Cell Therapy</a>

CLIA Requirements for Gene and Cell Therapy Programs

  • March 18, 2020

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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