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At the October 28 public meeting, held with the Reagan-Udall Foundation for the FDA on these issues, agency leaders emphasized transformational rather than incremental change, with one panelist calling for a “quantum leap.”

Susan Winckler, chief executive of the Reagan-Udall Foundation for the FDA, reframed the problem: harmonizing what sponsors prepare for review matters as much as harmonizing the review structures.

Medidata Link received a Reagan-Udall Foundation Innovation Award in 2022.

The agency sent a letter to formula makers on July 13 urging vigilance in choosing ingredients, has asked international expert bodies to assess spore-forming pathogens in infant formula, and is reviewing a September report from a Reagan-Udall Foundation…

To address those gaps, we have started engagement with the botanical community by holding a roundtable with the Reagan-Udall Foundation for the FDA to start the dialogue with key stakeholders to better understand the barriers they see.

The meeting on October 28 runs from 1:00 to 5:00 p.m. ET, in person at White Oak, or online, with registration through the Reagan-Udall Foundation.

Sutter noted that repurposing has become an administration priority, citing recent work on a Leucovorin labeling change and a Reagan-Udall Foundation meeting on repurposing.

To solicit feedback on the Rare Disease Framework Initiative from patients and disease advocates, industry, and others, the FDA will host a meeting at the FDA’s White Oak campus. The meeting will be facilitated by the Reagan-Udall Foundation for the FDA…

The agency further announced a “Fit-for-Purpose Rare Disease Framework Initiative” public meeting being convened in collaboration with the Reagan-Udall Foundation on October 28, 2026.

FDA holds a public meeting at White Oak on 28 October, facilitated by the Reagan-Udall Foundation, and Medical Daily reports comments are open through 11 December. FDA says only about 5% of rare conditions have an approved treatment.