This Week Inside HHS, FDA, and the NIH (January 26-30, 2026)

Modified on March 5, 2026 to remove the “subscribe” option. This blog has been retired and replaced by the S.P.I.R.I.T. newsletter.

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Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!

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Welcome to This Week Inside HHS, FDA, and the NIH!

Updates from the prior week from agencies that impact research and public health.

As a general reminder, any questions you may have about legal information within this article should be discussed with your attorney or legal counsel at your institution.

Table of Contents:

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Inside HHS

HHS issued a notice rescinding several Office for Civil Rights (OCR) Documents Under Executive Order 14192. Further details can be reviewed for each of the documents that were rescinded below:

• OCR Letter to University of Vermont Medical Center
• 3 Letters Concerning 45 CFR 75.300, RFRA, and Foster Care
• Guidance on Equitable Administration of COVID Vaccines
• Letter Rescinding a Notice of Violation Letter Concerning California’s Violation of the Weldon Amendment Conscience Protection

HHS issued another notice by the OCR rescinded “Guidance to Nation’s Retail Pharmacies: Obligations under Federal Civil Rights Laws to Ensure Nondiscriminatory Access to Health Care at Pharmacies,” issued on September 29, 2023 (2023 Guidance) as revised guidance to “Guidance to Nation’s Retail Pharmacies: Obligations under Federal Civil Rights Laws to Ensure Access to Comprehensive Reproductive Health Care Services,” originally issued on July 13, 2022 (2022 Guidance). You can read for further details on guidance rescission.

In a recent press release, HHS announced new guidance clarifying how pharmaceutical manufacturers can offer lower-cost prescription drugs directly to patients in a manner that’s low risk under the federal anti-kickback statute, so long as key safeguards are met. The guidance by the HHS Office of Inspector General (OIG), supports efforts to make medically necessary drugs more affordable while protecting patients and federal health care programs from fraud and abuse. To further support this effort, HHS OIG issued a RFI to gather public input on creating a formal regulatory safe harbor on matters related to direct-to-consumer drug sales.

HHS issued a RFI on a proposed rule, “Diagnostic Imaging Interoperability Standards and Certification.” Input from the public is requested on the potential adoption of diagnostic imaging technical standards and certification criteria for health information technology under the ONC Health IT Certification Program to better enable the access, exchange, and use of diagnostic images by health care providers and patients.

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Inside FDA

The FDA, Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada announced a collaborative symposium titled “Regulatory perspectives in good clinical practice, bioequivalence and good pharmacovigilance practice”. The symposium will be held June 2-4 2026, where participants will learn:

• Strategies for implementing quality by design to support proactive trial management and cultivate a quality culture that values critical thinking and transparency
• Key updates and practical application of ICH E6(R3)
• Approaches for balancing quality expectations with operational efficiency
• Regulatory expectations for incorporating decentralized and pragmatic elements into clinical trials
• Strategies to ensure participant safety and data reliability enabling reliable decision-making throughout the clinical trial lifecycle
• Clinical and bioanalytical challenges in bioequivalence studies
• Updates on regulatory collaborations, inspections and remote assessment practices
• Updates on regulation, guidance, policies and initiatives from each agency
• Pharmacovigilance inspection metrics, common inspection findings and harmonization efforts

The FDA issued a warning letter issued to the Center For Immunology Science, LLC‘s role as a sponsor for the clinical investigation of the investigational drug, heat-killed Mycobacteria smegmatis:

• The sponsor failed to submit an Investigational New Drug application (IND) for the conduct of a clinical investigation with an investigational new drug that is subject to 21 CFR 312.2(a) [21 CFR 312.20(a), 312.20(b), and 312.40(a)].
• During FDA’s inspection, the heat-killed Mycobacteria smegmatis was intended for use as a drug, not as a dietary supplement, for the clinical investigation conducted under Protocol CISMX-001.
• Therefore, the Center for Immunology Science was required to submit an IND before initiating and conducting the clinical investigation.

This week also marks the 120th anniversary of the FDA. In honor of this occasion, the FDA recently unveiled an official agency seal, its first ever. FDA at a Glance was also published by the FDA’s Office of Economics and Analysis (OEA). OEA’s mission is to provide public health, economic, and strategic analysis and evaluation to inform FDA’s policy and rulemaking decisions. You can also review Center for Devices and Radiological Health (CDRH)’s 2025 annual report highlighting the center’s performance last year.

Lastly, the FDA re-issued their Clinical Decision Support Software guidance published earlier this month.

• This guidance clarifies FDA’s thinking on the types of clinical decision support (CDS) software functions that are excluded from the definition of device by the criteria in section 520(o)(1)(E) of the FD&C Act (“Non-Device CDS criteria”).
• Further clarity of FDA’s existing digital health policies were included with respect to software functions that meet the definition of a device.
• The FDA intends to consider different kinds of software functions, including Non-Device CDS software functions and device software functions.

The FDA issued a RFI for a future public workshop series entitled “Rare disease Innovation, Science, and Exploration (RISE) Workshop.”

• The purpose of the public workshops is to focus on challenges that are common to multiple diseases or a class of diseases, and for which evolving science offers innovative solutions.
• The workshops will primarily focus on cross-cutting or common issues and will not be focused on any specific product under review by the FDA.

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Inside NIH

The NIH is removing AIDS application due dates from the application process. This policy change is effective for applications submitted for January 2027 and later Advisory Council Reviews. HIV/AIDS applications must be identified, segregated, and their status validated in manual processes outside of the normal referral stream. With this shift, HIV/AIDS applications being submitted on the standard receipt dates will continue to have three receipt dates per year, four months apart from one another, as they had with the previous AIDS receipt dates. The change will also lift the administrative burden on recipients of trying to determine if their application met current NIH guidelines for “AIDS research”. This corresponding press release explains the policy change and concludes with Q&A for extramural researchers.

The Government Accountability Office (GAO) reissued the NIH: Assessing Efforts to Improve Animal Research Could Lead to Greater Human Health Benefits report. Originally published in December 2024, GAO reissued this report to reflect corrected information of NIH’s spending on animal research.

Next, NIH implemented another major policy shift. Basic Experimental Studies Involving Humans (BESH) will no longer be subject to the requirements under the NIH Clinical Trial Definition.

• The BESH definition from 2014 stemmed from broader stewardship initiatives to ensure all NIH-supported research involving human participants are subject to rigorous standards.
• Because policies related to results dissemination have changed since 2014, and as part of ongoing efforts to reduce administrative burden, effective for applications submitted to due dates on or after May 25, 2026, the NIH will no longer characterize BESH as clinical trials. 

Finally, NIH will continue to update their Strengthening Replication and Reproducibility of NIH-funded Research site, to keep the scientific community informed of their initiatives including:

• Driving effective NIH replication and reproducibility
• Incentivizing replication and reproducibility sciences across the research enterprise
• Institutionalizing replication and reproducibility as a scientific discipline

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I hope you found this bite-size weekly update helpful!