The FDA's FDORA mandate is now in effect. Phase 3 and pivotal trial sponsors must submit Diversity Action Plans—and sites that can't hit enrollment targets will be deprioritized. Here's everything you need to know, plus an actionable checklist.
The FDA DAP requirement under FDORA is still in effect — and sponsors are already vetting sites on compliance readiness. What you need to do before the enforcement window opens, plus a 5-step action checklist.
How does your site compare? Therapeutic-area-specific FDORA enrollment benchmarks across oncology, cardiology, CNS, nephrology, and rare disease—plus what top-performing sites actually achieve.