Coverage

Palvella Therapeutics Q3 2026 Earnings Call Transcript
Palvella Therapeutics recently attended the FDA’s public meeting on the initiative held on October 28th in partnership with the Reagan-Udall Foundation.
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Delivering Answers and Hope for Rare Disease Families
Last month, the FDA took a bold leap forward by launching the Rare Disease Framework Initiative with a public meeting that included feedback from 75 members of the rare disease community; I was honored to participate in this meeting, and we will be…
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The Flexibility Papers No. 3: Old Drugs, New Possibilities – Repurposing as Part of the Rare Disease Framework
On August 5, 2026, FDA and the Reagan-Udall Foundation for the FDA convened a public meeting on drug repurposing.
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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.
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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.
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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…
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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…
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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…
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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.
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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…
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