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FDA’s total request of $7.2bn for FY 2025, an increase of $341m from the FY 2024 numbers, “will allow the agency to continue to leverage new and emerging technologies,” and unite the Human Foods Program under “a single line of authority,” FDA…

This news that Reagan-Udall Foundation for the FDA and the ASH Research Collaborative have established a new Real-World-Evidence Consortium for Sickle Cell Disease which aims to "develop consensus recommendations on clinical outcomes important to…

WASHINGTON—House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) today opened a hearing titled “Oversight of the U.S. Food and Drug Administration” to bring transparency to a pattern of issues within the U.S. Food and Drug…

FDA’s Center for Veterinary Medicine is looking to modernize its legal authority and spur innovation over the next several years, according to CVM Director Tracey Forfa. Read more

The U.S. House Oversight and Accountability Committee will question U.S. Food and Drug Administration Commissioner Robert Califf as part of an investigation into the agency’s handling of tobacco and nicotine products regulation, among other issues,…

On December 18, 2023, Dr. Brian King, the Director of FDA’s Center for Tobacco Products announced the Center’s new five-year strategic plan which outlines the Center’s programmatic and workforce initiatives and includes five goals, ten outcomes, and…

Today, the FDA is releasing several scientific review policy memoranda that provide a snapshot of the FDA's internal thinking on certain topics within the premarket tobacco review process.

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…

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…

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…