The FDA appointed longtime oncology regulator Richard Pazdur to lead its Center for Drug Evaluation and Research (CDER) while senior officials publicly sketched a new regulatory approach to accelerate individualized therapies. Pazdur’s selection—announced amid agency turmoil—was framed as a stabilizing move by FDA leadership. Separately, FDA officials Martin Makary and Vinay Prasad outlined a “plausible mechanism” pathway to streamline approvals for highly individualized therapies, arguing certain bespoke gene‑editing treatments could meet approval standards using mechanistic data plus targeted evidence. The concept was presented in major forums and signaling documents aimed at making rare‑disease, one‑off therapies more tractable for sponsors and regulators. Clarification: the "plausible mechanism" pathway refers to a regulatory route that allows approval based on strong mechanistic rationale and limited clinical evidence for treatments tailored to ultra‑rare patients, not a blanket relaxation of standards for broad populations. Stakeholders will scrutinize how the pathway is operationalized and the evidentiary bar for safety and manufacturing consistency.