News

Endpoints News Executive Editor Drew Armstrong leads a conversation on China biopharma at the Financial Times summit, with Susan Winckler, CEO of the Reagan-Udall Foundation for the FDA, and Caitlin Frazer, executive director of the National Security…

Co-sponsored by XPRIZE Healthspan and ARPA-H's PROSPR program, this public meeting — convened by the Reagan-Udall Foundation for the FDA — will bring together FDA leadership, select awardees, academic researchers, product developers, clinicians, and…

The U.S. biotech industry is facing a major global rival for the first time. In response to the Chinese life science industry’s rapid growth, U.S. policymakers and regulators are racing to support Western innovation while maintaining patient safety.

Oncology clinical trials represent a dynamic frontier where site selection optimization directly influences the pace of innovation and the relevance of therapeutic advances.

In September 2024, a stakeholder roundtable report published by the Reagan-Udall Foundation for the FDA indicated that industry stakeholders may not be aware of or prepared to be in compliance with the rule by January 2026.

Moderator Michael McCaughan and Dr. Amy Abernethy kicked off the fireside chat by reflecting on the evolution of RWD, including prior efforts such as the Friends RWD Pilot 1.0 Project and the COVID-19 Evidence Accelerator led by Friends and the Reagan-…

The FDA Public Engagement Staff, along with the Reagan-Udall Foundation, hosted the virtual event that was moderated by Aviva Strategies. The listening session provided a direct connection between the agency and the PF community allowing for better…

A new report from the Reagan-Udall Foundation for the Food and Drug Administration (FDA) has distilled longstanding challenges in rare disease drug development into 20 specific recommendations, aiming to consolidate years of regulatory dialogue into an…

I want to highlight a new article, “Primary mitochondrial diseases: A rare disease virtual workshop,” which distills key insights from the Reagan‑Udall Foundation for the FDA and FDA virtual workshop held on May 22, 2025.

The Reagan-Udall Foundation for the Food and Drug Administration isn’t exactly a unicorn among nonprofits—but it is something of a zebra.