Navigating FDA’s Guidance on Potency Assurance for Cellular and Gene Therapy Products

Unlock the essentials of FDA’s latest draft guidance on potency assurance for cell and gene therapy (CGT) products with Ergomed's Regulatory Dashboard.

 
This whitepaper provides biotech and pharma companies with practical steps for developing a robust potency assurance strategy. Discover best practices for quality control, risk management, and FDA communication to ensure that each product lot meets its intended therapeutic effect.
 
Equip your team with insights into potency assay design, critical quality attributes, and strategies to navigate the evolving regulatory landscape for CGT products.

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