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We also received similar feedback through several meetings in which FDA participated, including a two-day public meeting with the Reagan-Udall Foundation for the FDA in May 2023 and two listening sessions led by the Substance Abuse and Mental Health…

In May 2023, the Reagan-Udall Foundation hosted a 2-day public meeting with FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA), entitled “Considerations for Buprenorphine Initiation and Maintenance Care.”

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…

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 “…

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…

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…

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…

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…

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…