The blog Food Safety Matters episode on May 28, 2024 features an interview with Barbara Kowalcyk, PhD, MA, who discussed her role in the Independent Evaluation of FDA's Human Foods Program and her impressions of the proposed reorganization plan.
Regular engagement with patients participating in registries is key to ensuring they continue to participate in long-term follow-up about a disease’s progression or the effectiveness of a treatment, leaders of patient advocate groups who have created effective registries said this week. The advice comes as FDA officials struggle with how to keep patients in registries and are looking at possible incentives.
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 Commissioner Robert Califf said during the Agriculture, Rural Development, Food and Drug Administration subcommittee budget request hearing on April 18.
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 treating people with SCD and apply those standards to real-world data sets."
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 Administration (FDA) to ensure the FDA is prioritizing safety and effectiveness and incentivizing innovation.
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.
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, according to a press release.
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 several corresponding objectives.
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 that weighed potential use of accelerated approval for neuronopathic mucopolysaccharidoses disorders.
