Past Events

Anti-Aging Pills and Peptides aren’t the Legal Gray Area They Seem, But Proving They Work is Harder

There’s no agreement yet on which ones would work for aging. Candidates were discussed at a public meeting in May 2026 held by the Reagan-Udall Foundation for the FDA and the Advanced Research Projects Agency for Health.

Clinical Supply Label Data: The Fields That Cause Mislabeled Kits

... FDA announced a joint public meeting with the Reagan-Udall Foundation on potential medication error risks with investigational drug container labels.

Modernizing Global Data Exchange: Reagan-Udall Foundation to Host Public Meeting

The Reagan-Udall Foundation for the US Food and Drug Administration will host a hybrid public meeting on November 5, 2026, to explore how to modernize the global exchange of regulatory data for medical products—an issue of particular importance to patients with rare diseases, who frequently wait the longest for therapies approved elsewhere in the world.

ByHeart Is “Discontinued” – But Its Founders Are Buying Perrigo’s Infant Formula Business

The FDA’s July 2026 industry letter, a joint FAO/WHO expert meeting that added botulinum-producing clostridia to the priority hazard list for powdered formula, and a Reagan-Udall Foundation roundtable all reached the same conclusion – there is no standardized method to find C. botulinum in formula, and the industry cannot rely on indicator testing to catch it.

Credit Where It Is Due on Formula Nutrients — and a Reminder That Fifty-Two Babies Were Paralyzed by Something Else

The Reagan-Udall Foundation’s September report, from a roundtable funded in part by ByHeart and the International Dairy Foods Association, found that there is no standardized method for detecting these spores in formula and that the indicator test the industry relies on can miss spores at levels high enough to make babies sick.

The Flexibility Papers, No. 1: First Principles for a Rare Disease Framework

Yesterday, FDA and the Reagan-Udall Foundation for the FDA convened a public meeting to kick off stakeholder engagement on FDA’s new Rare Disease Framework Initiative.

The Flexibility Papers, No. 2: Beyond Listening—Making Patient Input Matter

On October 16, 2026, FDA’s Rare Disease Innovation Hub, in collaboration with the Reagan-Udall Foundation for the FDA, convened a public meeting on The Patient Voice in Rare Disease Medical Product Development, which emphasized the importance of incorporating patient perspectives early and often throughout product development.

FDA Announces Rare Disease Framework Initiative, Invites Input on Potential Regulatory Changes

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.”

Botanicals: Ask For Reuse, Not Relief

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 Named by IDC MarketScape™ as a Leader in Worldwide Life Sciences R&D RWD/RWE Data Platforms, Technology Solutions, and Consulting Services

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