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Authored By: Tasha Mohseni
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:
Inside HHS
Secretary Robert F. Kennedy, Jr. launched the nationwide “Take Back Your Health” Tour in Pennsylvania. At the State Capitol in Harrisburg, Secretary Kennedy joined more than a dozen Pennsylvania legislators to highlight the Trump administration’s first-year public health accomplishments of the President’s second term, including unveiling a new food pyramid, cutting waste, fraud, and abuse in Medicaid, and securing Most Favored Nation agreements that lower prescription drug costs for Americans.
Inside FDA
FDA’s Health Information Technology Advisory Committee (HITAC) announced their meeting schedule for 2026. All meetings are open to the public. They also announced the availability of the following guidance documents:
- M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality
- Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval
- Cuffless Non-invasive Blood Pressure Measuring Devices โ Clinical Performance Testing and Evaluation
Next, the FDA ImportShield Program (FISP) has dramatically enhanced their ability to stop dangerous imports at U.S. borders. Specifically, they reported increased processing speed by 66%, boosted monthly volume capacity by 33%, and reduced staff hours by 20%, saving approximately 3,388 hours each month. This is only after four months of data collection.
- FISP streamlines the FDAโs import review process by combining five separate regional teams into one centralized operation.
- By leveraging time-zone coverage and focused commodity expertise under unified management, the program improves efficiency, consistency, and accountability in import decision-making.
Finally, the FDA announced it will begin accepting applicationsโฏon February 1,โฏ2026,โฏforโฏtheโฏPreCheck โฏPilot Program. Though more details will be released after Feburary 1st, the PreCheckโฏ Pilot โฏProgram will selectโฏan initial cohort ofโฏnew pharmaceutical manufacturing facilities. These facilities will be selected based on overall alignment with national prioritiesโฏsuch asโฏproducts to be manufactured, phase of facility development, timeline to producing pharmaceutical productsโฏfor theโฏU.S.โฏmarket, and innovation in facilityโฏdevelopment.
Inside NIH
The NIH issued a notice regarding an Update to Guidance on Prompt Reporting to OLAW Under the PHS Policy on Humane Care and Use of Laboratory Animals. The PHS policy had six major revisions to provide clarity to reporting requirements, including:
- Clarification on how reporting requirements apply based on the scope of the institutionโs Animal Welfare Assurance. This can be found in the sentence underneath the first paragraph in the section discussing examples of reportable situations.
- Clarification on situations that may impact activities subject to the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy). This is the final bullet in the section discussing examples of situations where reporting is required.
- Addition of examples to the list of situations that normally are not required to be reported to OLAW. These are the final three bulleted items in the section on examples of situations where reporting is not normally required.
- Updates to the guidance for inclusion of award numbers and funding sources in reports to OLAW. These updates can be found in the second and third bullets in the section regarding information to be reported.
- Clarification on how reporting requirements apply when federal entities have a memorandum of understanding (MOU) with OLAW that applies the PHS Policy to activities they conduct or fund involving live, vertebrate animals used or intended for use in research, research training, experimentation, or biological testing or for related purposes (PHS Policy section III). This is introduced in the background and is clarified in the section on information to be reported.
- Clarification that the signature of the Institutional Official (IO) on the final report to OLAW provides verification of compliance with PHS Policy section IV.F.3. This can be found in the section on information to be reported.
Next, NIH issued another notice with respect to eRA Commons. NIH will require that all prior approval requests be submitted in eRA Commons Prior Approval Module for all grant and cooperative agreement awards. This requirement is effective 30 days from the date of when the notice was issued.
Another major policy update was issued with respect to human fetal tissue (HFT). Effective on date of issuance, NIH funds will not be permitted for research using HFT from elective abortions. HFT obtained from miscarriage or stillbirth for research may use NIH funds in accordance with NOT-OD-15-143 and NOT-OD-16-033. NIH Director, Dr. Bhattacharya released a statement on the rationale of this decision. Given that HFT research projects have decreased more than 50% between 2019 and 2024, Bhattacharya emphasized the that they will continue to assess other research areas ripe for modernization. NIH will engage the community in identifying emerging areas in which additional investments could bolstered alternative, validated models. As reaffirmed in the press release, NIH will soon seek public comment on emerging biotechnologies to reduce or potentially replace reliance on human embryonic stem cells to drive modernization.
I hope you found this bite-size weekly update helpful!
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