FDA sets new standard for real-world evidence, cites Truveta's role

The FDA is setting a new standard for real-world evidence (RWE)—one rooted in transparency, reproducibility, and regulatory-grade rigor. In its new resource, the FDA highlights how RWE has informed approvals, safety communications, and labeling updates over the past decade. This growing reliance on RWE underscores the importance of trustworthy, auditable data that can stand up to regulatory review. At Truveta, we’re proud to deliver regulatory-grade, real-world data that are directly traceable to their source, fully auditable, and trusted by regulators to support high-impact, data-driven decisions. 🔍 Learn more: https://tr.vet/46RhExj

🔎 Transparency is the new standard for regulatory-grade real-world evidence. The FDA has launched a new resource cataloging more than a decade of case studies where RWE informed approvals, safety communications, and labeling updates. This initiative signals a growing expectation: regulators want evidence that is transparent, reproducible, and fit-for-purpose. We've invested deeply to deliver exactly that: Truveta Data is directly traceable to its source, fully auditable, and trusted by regulators. With complete provenance, audit-ready workflows, and the most complete real-time EHR dataset in the US, we provide regulatory-grade RWD that meets and exceeds FDA standards. 📖 Read our perspective on the FDA’s new initiative: https://tr.vet/4779l1H

Real-world CMC challenges require practical, forward-thinking solutions. This week's ASK ELIQUENT explores how ELIQUENT Experts approach regulatory expectations. Whether it’s comparability planning, delivery system changes, or navigating EMA requirements, our experts help sponsors anticipate challenges and move forward with confidence. See how strategy translates to submission success with Ask ELIQUENT → https://lnkd.in/eHCQkXWz

Delighted to see this thought leadership feature go live on #EliquentLifeSciences LinkedIn page. I had the opportunity to share insights from a recent client interaction, exploring the regulatory and CMC considerations for a vial-to-pre-filled syringe switch during clinical development, including data requirements, comparability, and EMA expectations. I’m excited to play a small part in shaping how our industry moves toward more adaptive, insight-driven regulatory models that enable faster, smarter access to medicines.

🎥 Highlights from RAPS Convergence 2025 | 5 Key Takeaways Shaping the Future of Regulatory Affairs RegASK joined regulatory professionals from around the world at Regulatory Affairs Professionals Society (RAPS) Convergence 2025 in Pittsburgh to explore how technology and collaboration are redefining the regulatory landscape. From AI-human collaboration to global convergence, the event highlighted how regulatory affairs is becoming smarter, faster, and more responsible. Watch our video recap to see the 5 key trends driving the future of regulatory excellence. 👉 Stay ahead with AI-driven Regulatory Intelligence. Book a demo with RegASK: https://lnkd.in/dZt2KkiB #RAPSConvergence2025 #RegASK #RegulatoryIntelligence #AiinRegulatoryAffairs #RegTech #RegulatoryInnovation #GenerativeAI #AgenticAI #LifeSciences #Compliance   Kelli Madden, Deanna Coscia, Caroline Shleifer, Remie Abdel Latif, Amenallah Reghimi, Oliver Stein, Zach Poole, Josh Lambeth, MBA, Fabienne JAUTARD

Dr. Scott Berry recalls how Dr. Lisa LaVange at the FDA offered a clarifying perspective: Type 1 error should be counted only when a drug is approved but there is benefit in none of the subgroups. If any subgroup shows benefit, this is considered a mixed result—not a Type 1 error. This distinction is critical for enrichment and platform trial design, influencing how regulatory error rates are assessed. Hear the full discussion on "In the Interim…" Episode 32. https://lnkd.in/g93dakw5

The FDA’s latest update shows just how central real-world evidence has become to regulatory decision-making. What stands out most is the focus on transparency—not just what the data show, but where they come from and how they’re generated. That’s exactly what Truveta Data is built for: regulatory-grade, fully auditable data directly traceable to their source, trusted by regulators, and used in submissions today. Learn more: https://tr.vet/46RhExj

The FDA’s latest update shows just how central real-world evidence has become to regulatory decision-making. What stands out most is the focus on transparency—not just what the data show, but where they come from and how they’re generated. That’s exactly what Truveta Data is built for: regulatory-grade, fully auditable data directly traceable to their source, trusted by regulators, and used in submissions today. Learn more: https://tr.vet/46RhExj

The FDA’s latest update shows just how central real-world evidence has become to regulatory decision-making. What stands out most is the focus on transparency—not just what the data show, but where they come from and how they’re generated. That’s exactly what Truveta Data is built for: regulatory-grade, fully auditable data directly traceable to their source, trusted by regulators, and used in submissions today. Learn more: https://tr.vet/46RhExj