Industry concerns about compliance with the U.S. Food and Drug Administration’s (FDA’s) impending Food Traceability Final Rule, which fulfills Section 204(d) of the Food Safety Modernization Act (FSMA), have been brought to light in a recently released report based on a series of roundtable discussions conducted in spring 2024 by the Reagan-Udall Foundation.

By December of 2023, a reorganization package based in part on the findings and recommendations of the Reagan-Udall Foundation's evaluation of the agency's infant formula response, and feedback from external and internal stakeholders, was completed.

We want to see the FDA use this momentum to keep focus on its core mission of food safety, make the cultural changes called for in the Reagan Udall Foundation’s report, and send a distinct signal that a strong, federal agency is protecting the health and safety of consumers.

The Reagan-Udall Foundation for the FDA is leading an initiative to identify holistic approaches to address opportunities and challenges in animal health and veterinary medicine.

In establishing the Hub, FDA gathered feedback from stakeholders through a public meeting, held on Oct. 16, 2024 in collaboration with the Reagan-Udall Foundation.

In collaboration with the Reagan-Udall Foundation for the FDA, we hosted a public meeting, Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub, on October 16, 2024.

Federal agencies recently convened in a pivotal public meeting, hosted by the Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA), to discuss emerging treatments for post-traumatic stress disorder (PTSD), with a focus on the potential of psychedelics.

The reorganization had its origins in the Reagan-Udall Foundation report, which was released less than two years ago. The report focused on ways to clarify the mission of the human food program and achieve more urgency in preventing foodborne illnesses.

The oncology quality, characterization, and assessment of real-world data (Oncology QCARD) Initiative was formed to develop a set of minimum study design and data elements needed to evaluate the fitness of the real-world data (RWD) source(s) proposed in an initial study concept as part of early interaction with scientific reviewers.

The rare disease policy calendar in Washington has been packed. Highlights have included an advisory committee meeting for a Barth syndrome treatment from Stealth BioTherapeutics, a meeting about FDA’s Rare Disease Innovation Hub convened by the Reagan-Udall Foundation, the NORD Breakthrough Summit, BIO’s Patient & Health Summit, and a Haystack Project congressional briefing.