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LDT Industry Education: Record Keeping and Adverse Event Reporting
Record Keeping and Adverse Event Reporting:
Medical Device Reporting, Corrections and Removals and Quality System Complaint Requirements
LDT Industry Education
Steven A. Grossman, Jeff Shuren, and the Real-World Evidence Collaborative Recognized with Innovations in Regulatory Science Awards
(October 11, 2024) Steven A. Grossman, JD; Jeff Shuren, MD, JD; and the Real-World Evidence Collaborative will receive the Reagan-Udall Foundation for the FDA’s 2024 Innovations in Regulatory Science Awards on December 10. The prestigious awards recognize outstanding contributions to regulatory science and public health in three categories: Leadership, Innovation, and Advocacy/Policy.
Keller & Heckman Law: A New Day Dawns at FDA with the Establishment of the Human Foods Program
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.
Medidata: What’s Driving the Adoption of Clinical Trial to Real-world Data Linkage?
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.