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Rare Diseases: CBER Looks To ‘Lean Into’ Accelerated Approval, Align More With CDER - Pink Sheet Citeline
US FDA biologics center officials spoke about their efforts to increase collaboration and harmonization with the drugs center, and to internally involve more review disciplines in evaluating biomarker evidence, during a Reagan-Udall Foundation meeting that weighed potential use of accelerated approval for neuronopathic mucopolysaccharidoses disorders.
Amidst spreading infectious diseases and climate change, US FDA should renew its focus on neglected tropical diseases - PLoS One
In 2015, the United States Food and Drug Administration (US FDA) and other Department of Health and Human Services agencies helped respond to a public health emergency concerning Zika Virus during which 5,600 cases of the virus were reported in the United States mainland and 37,000 cases in Puerto Rico and other US Territories.
Online Controlled Substances Summit
The Food and Drug Administration (FDA) and the Reagan-Udall Foundation for the FDA convened the fifth Online Controlled Substances Summit.
2024 Annual Public Meeting
Each year, the Reagan-Udall Foundation for the FDA conducts an annual public meeting to discuss its activities in support of the U.S. Food and Drug Administration.
Jim Jones Looks Toward FDA's Future - Quality Assurance Magazine
Every organization goes through ups and downs. And the Food and Drug Administration is no different.
But the stakes are higher when you’re tasked with protecting public health. So, it’s understandable when “Put the F Back in FDA” started trending online in 2022 as a way to knock the agency for the perception that it focused too much on things that were not its Human Foods Program, such as drugs.