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USFDA Guidance: Potency Assessment of Active Immunotherapy Products & FAQ's on Developing Potential Cellular and Gene Therapy Products
Active immunotherapy products (ACTIMPs) are designed to treat existing diseases or conditions by inducing, stimulating, or modulating immune responses. Because their therapeutic effect depends on the interaction between the product and the immune system, demonstrating and maintaining product potency is an important part of development. The FDA has issued draft guidance on Potency Assessment of Active Immunotherapy Products, providing recommendations for developing and evaluat
Sharan Murugan
3 hours ago4 min read