Regulatory Daily Summary: What Happened on October 29, 2026

HHS permits compounding of six peptides under conditions

HHS said it will not take enforcement action against specified pharmacies, federal facilities and licensed physicians that compound six peptides if they meet the policy’s requirements.12 The six substances received favorable votes at a July meeting of the Pharmacy Compounding Advisory Committee and are on FDA’s Interim Access List.1

The policy sets requirements for substance identity, routes of administration, delivery devices, sourcing, certificates of analysis and reporting.1 Any delivery device must be an FDA-cleared 510(k) syringe, and bulk suppliers must be FDA-registered and meet applicable manufacturing requirements.1 Each product may contain only one covered active ingredient, and its label must identify it as compounded and not for resale.1

The policy does not make the products FDA-approved and remains in effect until a final rule determines whether each substance belongs on the 503A bulks list.1 HHS may reconsider the policy if safety or quality concerns arise.1

Treasury proposal leaves NewCo deal impact in dispute

The Treasury Department proposed restricting U.S. investment in Chinese biotech, prompting industry debate over the proposal’s reach.3 A Treasury official said licensing deals are excluded, an exemption central to the disagreement over the rule’s effects.3

Western investors have increasingly formed NewCos over the past three years to develop assets licensed from Chinese biotech companies.4 The arrangements pair licensed assets, often supported by clinical data, with funding for global development, while giving licensors cash and potential future returns.4 Equity in a NewCo can form part of a licensor’s potential return, and that feature could be affected even though licensing deals are exempt, according to the accounts of the proposal.34

FDA clears United Therapeutics’ Phase 1 trial

FDA cleared United Therapeutics to begin a Phase 1 trial of Treprostinil-Iloprost SMI, an investigational combination of two prostacyclin analogues.5 The open-label, single-ascending-dose study will assess pharmacokinetics, safety and tolerability in healthy participants.5

The company intends the treatment to provide as-needed relief during acute symptom flare-ups between scheduled maintenance doses for pulmonary arterial hypertension.5 If the initial study has positive results, United Therapeutics expects to start a Phase 2 trial in patients in 2027.5

FDA begins stakeholder work on rare-disease framework

FDA and the Reagan-Udall Foundation held a public meeting to begin stakeholder engagement on the Rare Disease Framework Initiative.6 FDA is seeking input on how to revise its rules and guidance, internal practices, reviewer training and organizational structure for rare-disease drug development.6

At the meeting, attorney James Valentine presented principles developed with colleagues at Hyman, Phelps & McNamara for choosing a development pathway, including disease and product characteristics, available evidence, severity, unmet need, patient views and benefit-risk.6 The authors argue that FDA should treat rarity as a continuum and use scientifically appropriate approaches across disease populations while maintaining scientific rigor and statutory standards.6 Written comments are due December 11, 2026.6

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