Coverage

Food Navigator USA: Does FDA's proposed front-of-pack nutrition labeling miss the mark?
Her sentiments echo concerns raised by the Rudd Center for Food Policy & Health at a public meeting hosted by The Reagan-Udall Foundation for FDA in November 2023.
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Food Logistics: FSMA 204 Compliance to Fundamentally Change How the Cold Chain Works
“Our team has had over 185 meetings across industry sectors and answered over 400 questions through our technical assistance network. We also worked with the Reagan-Udall Foundation to meet with industry through a series of roundtables and the public…
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EIN Presswire: FDA recommends changes to labeling for transmucosal buprenorphine products indicated to treat opioid use disorder
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…
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Federal Register: Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence
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.”
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Ultragenyx: Ultragenyx Submits Biologics License Application to the U.S. FDA for UX111 AAV Gene Therapy for the Treatment of Sanfilippo Syndrome Type A (MPS IIIA)
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…
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Providers, You Are the Missing Piece: Your Patients with OUD Need You
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 “…
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R Street Institute: Vaping goes to the Supreme Court
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…
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Food Safety News: FDA’s sluggish process is failing to protect Celiacs
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…
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U.S. Food & Drug Administration: FDA Patient Engagement Partnerships
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…
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Food Safety Magazine: Report Highlights Industry Concerns With FSMA 204 Compliance, Barriers to Implementation
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…
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