Earlier this year, Ultragenyx reached agreement with the Agency that CSF HS can be used as a surrogate endpoint for accelerated approval based on the body of data presented by the company, along with a consortium of academics and other industry sponsors at a workshop hosted by the Reagan-Udall Foundation for the FDA in February 2024.

Drs. Robert Califf and Marta Sokolowska underscore the distinctive advantages primary care providers can bring to positively impacting the lives of people with opioid use disorder, referencing the Foundation’s virtual public meeting exploring “Considerations for Buprenorphine Initiation and Maintenance Care.”

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In the fall of 2022, the Reagan-Udall Foundation—an independent organization established by Congress to advance the mission of the FDA—evaluated the CTP and identified several key areas for improvement. Released in December 2022, the report outlined 15 things the CTP must improve to effectively implement the regulatory goal of the organization’s mission: the protection of public health.

Jax’s Citizen Petition represents a perfect opportunity for the FDA’s Human Foods Program under Deputy Commissioner Jones to lead by example and break away from the Reagan-Udall Foundation’s finding that the FDA’s “culture creates an environment where decision-making is unacceptably slow” and from an external perspective appears “sluggish and non-responsive to public health concerns.”

Through this collaboration, the Public Engagement Staff and the Foundation are working together on FDA Patient Listening Sessions to enhance FDA’s clinical and regulatory understanding of diseases and conditions and provide a common understanding of the most urgent needs of patients, caregivers and advocates.

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.