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.
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).
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.
TOBACCO PROGRAM REVIEW PANEL ENTERS DAY 3 OF LISTENING SESSIONS — The five-person expert panel tasked with evaluating the FDA’s tobacco regulatory program will embark on its final listening sessions from industry, legal and public health experts today.
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Members of the Food and Drug Administration’s food program evaluation panel have a big job as they develop recommendations for FDA guidance.
At a public meeting last month and in the hundreds of comments received through the online portal members of a Reagan-Udall Foundation panel tasked with examining the agency’s “structure/leadership, authority, resources and culture” were told that problems in the food program are deep-rooted and complex, leading to a lack of accountability and delayed decision-making.
Editor’s note: This is a letter sent by a large coalition of consumer and industry groups to Jane Henney, the chair of the Independent Expert Panel – FDA Human Foods Program of the Reagan-Udall Foundation, that is charged with investigating operations at the Food and Drug Administration.
Dear Dr. Henney:
The undersigned coalition appreciates the opportunity to submit comments to the Reagan-Udall Foundation as part of its review of the foods program at the Food and Drug Administration (FDA).
Overdose prevention, reduction in opioid and other substance use disorders (SUD), and effective treatment and support for those with SUD are key priorities for the U.S. Food and Drug Administration and personally for me as Commissioner.
Yesterday and today in Washington, D.C., the Reagan-Udall Foundation is facilitating a public meeting of its Independent Expert Panel on food.
The independent expert panel has been charged with evaluating the structure, leadership, authorities, resources and culture of the FDA’s human foods program.
Anyone who has heard Frank Yiannas speak has probably heard his “mango” story. It dates back to his time working for the world’s largest retailer and prior to joining the Food and Drug Administration in 2018 as deputy commissioner for food policy and response. But the story underscores the important role technology can play in current efforts to improve the safety of our food supply and how agency leaders are trying to be more transformative.
During the COVID-19 pandemic, as healthcare systems sought ways to better prevent, treat and manage a previously unseen infection, rapid access to promising novel investigational therapies based on emerging scientific evidence from clinical trials was crucial. This ‘early’ access pathway was via ‘compassionate use’ (CU) programmes, which are something I’ve been passionate about for many years.
