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The oncology quality, characterization, and assessment of real-world data (Oncology QCARD) Initiative was formed to develop a set of minimum study design and data elements needed to evaluate the fitness of the real-world data (RWD) source(s) proposed in…

The rare disease policy calendar in Washington has been packed. Highlights have included an advisory committee meeting for a Barth syndrome treatment from Stealth BioTherapeutics, a meeting about FDA’s Rare Disease Innovation Hub convened by the Reagan-…

Advancing real-world data research through the Innovation in Medical Evidence and Development Surveillance (IMEDS) program: an interview with Carla Rodriguez-Watson, Reagan-Udall Foundation for the FDA.

Food industry players across the value chain are frustrated by lingering questions about how to implement sweeping food safety changes that go into effect in little over a year, including fears of some stakeholders “going berserk” with new technology or…

Recently, the FDA has taken additional actions to clarify and streamline its policies regarding the EA process, including issuing guidance documents on EA, restructuring the FDA web page on EA, launching Project Facilitate (a call and information center…

Jones who was previously an official at the Environmental Protection Agency, was also on the Reagan-Udall Foundation panel that published an evaluation of FDA’s HFP which made recommendations for the reorganization of FDA’s HFP.

This came up early and often during the Reagan-Udall Foundation’s public meeting on Wednesday, “Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub,” that brought together rare disease patient advocates, academic researchers,…

So with MDMA-AT off the table, where does the field go next? A public meeting in September hosted by the Reagan-Udall Foundation for the FDA in sought to answer that question.

The industry, consumer and state regulatory members of the Fresh Produce Coalition (FPC) are pleased that the U.S. Food and Drug Administration is supporting the Reagan-Udall Foundation’s (RUF) facilitation of an inclusive stakeholder dialogue to…

Complex and disparately funded regulatory oversight for food and beverage products, spread out among many federal agencies, has created a regulatory mess that demands a radical fix.