The FDA’s Center for Biologics Evaluation and Research (CBER) issued draft guidance clarifying how cell and gene therapy sponsors can leverage prior knowledge across clinical, nonclinical, and manufacturing work. The agency detailed the types of previously generated information—public or platform-based—that can be applied to streamline certain development steps, rather than restarting evidence generation for each new program. For companies building next-generation autologous and in vivo therapies, the draft guidance signals an attempt to reduce duplication while keeping a structured evidence approach. Overall, the guidance emphasizes using established datasets and mechanistic rationale to support submissions, aligning cell and gene therapy review with the broader FDA push toward more efficient development pathways.