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Reg Roundup 1.2: Hot Items from Summer 2026

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Several developments from this summer generated enough attention on their own in trade press, law firm alerts, and conference programming that most people in this field will have seen at least a headline about one of them. While you may have read about these piecemeal, seeing these efforts described in one place highlights the volume of initiatives and the speed at which HHS and other federal agencies are moving. 

Remember: most of the dates listed in these Unified Agenda entries are aspirational and not set in stone.  If you aren’t sure how to read a Unified Agenda entry or a reginfo.gov listing, check out our companion piece walking you through these nuances here.

News You May Have Missed

HHS launched Operation TrialBlazer, a department-wide initiative to speed up and modernize clinical trials; several other items in this roundup are components of it. Announced June 22, 2026, TrialBlazer is a coordinated effort across HHS (including FDA, NIH, the Office of the National Coordinator for Health Information Technology, ARPA-H, and the HHS Office of Inspector General) aimed at reversing the trend of clinical trials moving overseas and restoring U.S. leadership in clinical research. On the FDA side alone, TrialBlazer bundles together: the Expedited IND Pilot Program covered later in this roundup; a new Phase 1 IND Navigator webpage and Phase 1 contact center aimed at smaller sponsors without large regulatory teams; draft guidance on dose selection for first-in-human trials using quantitative systems pharmacology; and a significantly revised draft guidance on what counts as substantial evidence of effectiveness, one that would let a single well-designed pivotal trial plus confirmatory evidence support approval in appropriate cases rather than requiring two independent trials. NIH’s side of TrialBlazer includes support for trials incorporating AI, human cell-based models, and real-world data, NCATS work on personalized CRISPR-based gene editing treatments, and NCI work streamlining cancer trial activation and enrollment. HHS press release | FDA actions page

Updates to the Common Rule (subpart A of 45 CFR part 46) are in active development. OHRP is working on a proposed rule to revise the Common Rule, aiming to “uphold protections for human subjects while reducing burden and ambiguity for investigators, institutional review boards, and research institutions.” The described changes include clarifying terminology, expanding exemptions for low-risk research, and building in flexibility for de minimis protocol review changes. This is currently logged in HHS’s Unified Agenda with a target NPRM date that has already passed (which is common for Unified Agenda dates). As of mid-October, the proposed rule had not yet been sent to OIRA for review. Unified Agenda entry

FDA’s single-IRB requirement for cooperative research has moved into the finalization stage. This rule would require U.S. institutions participating in multisite cooperative research to route domestic review through a single IRB, with specified exceptions, and would add recordkeeping requirements when an external IRB provides oversight. It was first proposed in 2022 and is now listed as being in the Final Rule stage in the Unified Agenda with a target publication date of December 2026.  When reginfo.gov shows that the final rule has been sent to OIRA for review, we will have a better sense of when this effort might be finalized. As of mid-October, it had not yet arrived at OIRA.  Unified Agenda entry

FDA launched a pilot aimed at speeding first-in-human trial starts, and it is one of the concrete pieces of Operation TrialBlazer described above. The Expedited IND Pilot pairs drug sponsors with “Qualified Research Institutions” and allows rolling review of IND application components rather than requiring a complete submission upfront. Sponsor-QRI pairs must apply jointly by October 30, 2026, with 8 to 10 partnerships expected to be selected, making this directly relevant to any institution positioning itself as a QRI. FDA press release

We want your feedback!

How did we do?  Too much? Wanted more? Are there items on which you’d like for us to publish a deep-dive?  Let us know on LinkedIn or provide your feedback here.

How to read a Reg Roundup:

Inaugural Edition of Reg Roundup: