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 asking for more than the law requires and before the national deadline.

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 to help with EA request submissions), simplifying the application form for single-patient requests so that form completion takes an estimated 45 minutes, and working with the Reagan-Udall Foundation to launch the Expanded Access Navigator website to help patients and physicians more easily locate relevant information about EA.

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, regulated industry, and other key stakeholders to discuss how the hub can best engage with members of the rare disease community and prioritize its work.

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 explore new strategies for produce safety.

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.

The report was prepared by an expert panel at the Reagan-Udall Foundation, convened at the request of Commissioner Califf, that was charged with assessing the processes and procedures, resourcing, and organizational structure for FDA’s Foods Program.

In 2022, Medidata Link (Medidata’s linkage technology) won the Innovation Award from the Reagan Udall Foundation for the FDA, highlighting the excitement from the regulatory community towards linkage’s potential to reduce trial costs, timelines, and patient burden.