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This is Episode 4 of "FDA Fridays," a special series from Cell & Gene: The Podcast, Chief Editor Erin Harris speaks with regulatory affairs expert Daniela Drago, Partner, NDA Partners, about how shifting FDA and CBER priorities under the current administration could influence the trajectory of cell and gene therapy development. From the impact of leadership changes and evolving policy directives to the role of funding allocations and public health priorities, Drago sheds light on what CGT developers and sponsors should be watching most closely. She explores regulatory modernization trends, including digital health integration, real-world evidence, and decentralized trial models, and offers practical guidance on how companies can best prepare for potential regulatory shifts while maintaining alignment with FDA expectations for safety, efficacy, and manufacturing rigor.

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