FDA wants to know: What's holding up the development of individualized cell and gene therapies?
The FDA on Wednesday said it’s looking to better understand the scientific challenges that are slowing the development of individualized cell and gene therapies.
The focus of its request for information, which comes on the heels of some heated debates between the agency and small sponsors, centers on the difficulties around these individualized cell and gene therapy quality and manufacturing specifics, nonclinical development (e.g., toxicology, proof of concept, biodistribution), assessments of safety and efficacy, and additional scientific needs, best practices, and opportunities for collaborations.
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