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Coverage
Last summer, when FDA Commissioner Robert Califf announced he’d asked the Reagan-Udall Foundation to review the agency’s foods program, the response around Washington wasn’t exactly positive.
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The Food and Drug Administration’s Human Foods Program lacks leadership and mission clarity, leading to slow decision-making and weak regulation of foodborne illness, according to a highly-anticipated, independent report on the FDA’s Human…
The Reagan-Udall Foundation, a group with close ties to the FDA, released a 51-page report Tuesday noting the need for a clear mission in the program and more urgency to prevent illness outbreaks. FDA Commissioner Dr. Robert Califf first …
The Food and Drug Administration’s food division has no clear leadership, avoids bold policy or enforcement actions, and fosters a culture that doesn’t adequately protect public health, according to a report issued on Tuesday by an agency-…
To help prevent outbreaks of food-related illness and problems like the formula shortage that left many parents in the US without adequate access to food for their babies, the US Food and Drug Administration needs a clearer mission and a different kind…
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…
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.
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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.
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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.
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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…