FDA Regulations for CAR T-cell Therapy

EP: 1.The Mission Behind CAR T-cell Clinical Trials

EP: 2.Key Challenges within CAR T-cell Clinical Trials

EP: 3.Approaching Institutional Biosafety Committee Approval for CAR T-cell Therapy

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EP: 4.FDA Regulations for CAR T-cell Therapy

EP: 5.The Future of Regulatory Processes in Cell and Gene Therapy

EP: 6.Site Selection for CAR T-cell Trials

EP: 7.Collaboration with Clinical Trial Sites

EP: 8.Patient Selection and Recruitment for Clinical Trials

EP: 9.Looking Towards the Future of CAR T-cell Trials

EP: 10.Final Thoughts

The regulatory landscape for CAR T-cell therapies is constantly evolving with the FDA establishing their own guidelines needed for approval. Often, the approval can be long and difficult to obtain. Panelists examine their own strategies that have increased collaboration and support from the FDA.