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Expert Panel Completes Operational Evaluation of FDA’s Human Foods Program
(December 6, 2022) Today, the Independent Expert Panel for Foods submitted its Operational Evaluation of FDA’s Human Foods Program to Dr. Robert Califf, Commissioner for Food and Drugs. The evaluation and report were facilitated by the Reagan-Udall Foundation at Dr. Califf’s request.
Reagan-Udall Foundation for the FDA Releases Snapshot 2022: A Changing Environment for FDA-Regulated Consumer Products
(December 2, 2022) Today the Reagan-Udall Foundation for the FDA (FDA Foundation) announces the release of “Snapshot 2022: A Changing Environment for FDA-Regulated Consumer Products.” This report outlines how the COVID-19 pandemic, and the prevalence of digital tools and technology are transforming the health care landscape, highlighting the need for industry and regulatory agencies to adapt.
Real-World Accelerator to Improve the Standard of collection and curation of race and Ethnicity data in healthcare (RAISE)
Improving the Collection and Curation of Race and Ethnicity Data in Health Care
Thursday, January 26, 2023
2-4 PM ET
Fundamental Flaws of Tobacco Control Act—and FDA’s Implementation - Filter Magazine
When Congress passed the the Tobacco Control Act in 2009, it amended the federal Food, Drug, and Cosmetic Act to give the Food and Drug Administration (FDA) the authority to regulate the manufacture, distribution and marketing of tobacco products for the first time.
Advocacy Group Suggests FDA Reforms - The Tobacco Reporter
The U.S. Food and Drug Administration has “significantly and substantially failed” to fulfill its congressional mandate to protect the public health, Americans for Tax Reform (ATR) told the Reagan-Udall Foundation in a letter.
Why Most Everyone Thinks FDA Needs a Real Shakeup -Food Fix
There are no shortage of battles, or even just sharp disagreements, over how food and agriculture policy should work. At times, it can get downright ugly.
Expanded Access Postings Not Promotional, Unless Done In ‘Promotional Context,’ US FDA Says - Pink Sheet
Updated guidance on expanded access program clarifies that sponsors do not risk enforcement for off-label promotion if they post investigational drug expanded access policies, although that fear already may have subsided.
Comments in FDA Assessment Suggest Agency in Disarray - Tobacco Reporter
The U.S. Food and Drug Administration is in disarray and influenced by outside forces rather than scientific research, according to several comments submitted to the Reagan-Udall assessment of the performance of the FDA’s Center for Tobacco Products (CTP).
Early Takeaways from Comments to Reagan-Udall's Expert Panel - POLITICO's Prescription Pulse
As the Reagan-Udall Foundation undertakes its review of the FDA’s tobacco program, a number of legal, industry and public health experts are presenting the expert panel with written and oral comments about the major issues they see with the Center for Tobacco Products’ processes and operations.