This Week Inside HHS, FDA, and the NIH (February 9-13, 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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Updates Since Last Week’s Edition

This section contains updates that became available AFTER the prior week’s edition was published:

• ACL Launches Phase 1 of Caregiver AI Prize Competition
• FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs

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Inside FDA

Inside CDER

CDER issued a warning letter to Dr. Mark S. Dacey for failing to obtain informed consent from a study participant prior to specimen collection. CDER empathized that failure to obtain informed consent before conducting study procedures jeopardizes the rights, safety, and welfare of participants. This denies participants the opportunity to fully assess the risks and benefits of their participation in the clinical investigation. As I reflect upon an article I wrote, I wonder if:

• Did Dr. Dacey receive adequate human subjects research ethics training? If so, was it adequate?
• Even if training was received and adequate, did Dr. Dacey understand the significance of completing this training?

I wrote a post on LinkedIn about this incident. This is why research ethics education is so important. Not only to take the training, but to understand how to apply the principles you’ve learned from the training.

FDA announced an opportunity for a limited number of drug manufacturing establishments to participate in the third year of the voluntary Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program. This voluntary program is for CDER-regulated drug products manufacturers to gain more experience with the assessment tool and process.

CDER has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone replacement therapy (HRT). According to this press release, risk statements related to cardiovascular disease, breast cancer and probable dementia were removed from the “boxed warning,” the agency’s most prominent safety-related warning.

The following guidance documents were released:

• Certification Process for Designated Medical Gases; Draft Guidance for Industry: public comment due by April 13, 2026

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Inside CDRH

The FDA has approved a first-of-its-kind device for the treatment of adult patients with locally advanced pancreatic cancer. According to this press release:

• Optune Pax, developed by Novocure, is a portable, non-invasive device that delivers alternating electrical fields, known as tumor treating fields (TTFields), to the abdomen
• TTFields work by physically disrupting the rapid cell division that is characteristic of cancer cells, while minimizing damage to healthy tissue
• The results showed that the addition of TTFields to standard of care chemotherapies gemcitabine and nab-paclitaxel (GnP) improved Overall Survival by approximately two months compared to GnP alone
• The FDA granted Breakthrough Device designation for the Optune Pax device in December 2024

Finally, CDRH announced the availability of the most recent Medical Device User Fee Amendments 2028 (MDUFA VI) meeting minutes:

• FDA-Industry MDUFA VI Reauthorization Meeting, January 21, 2026

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Inside CBER

CBER’s “Refusal to File” letter to Moderna received a lot of attention both on LinkedIn and various news media outlets. Moderna released the letter to promote transparency in the scientific community.

• I made a post about this update on LinkedIn as I had questions about it for those who work in the field

CBER announced its forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The meeting will be held on March 12, 2026, from 9 a.m. to 3:30 p.m. Eastern Time.

Finally, the following biologics received FDA approval letters this week:

• February 10, 2026 Approval Letter – 0.8% RESOLVE Panels, A, B, and C
• January 27, 2026 Approval Letter – THYMOGLOBULIN
• February 5, 2026 Approval Letter – YESCARTA
• February 11, 2026 Approval Letter – OMISIRGE

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Inside HHS

From the Office of Research Integrity (ORI), an HHS agency, released Dr. Daniel Andrade’s case summary involving research misconduct. Within the summary, ORI by a preponderance of the evidence found:

• Dr. Andrade intentionally and knowingly falsified and/or fabricated data included in two grant applications submitted for PHS funds
• He was engaged in research misconduct by intentionally and knowingly falsifying and/or fabricating for data under his DP2 and R21 grants

ORI proposed a three-year period of supervision under 42 CFR 93.407(a)(7) and a three-year period of prohibition from PHS advisory service under 42 CFR 93.407(a)(9).

The Centers for Medicare & Medicaid Services (CMS), another HHS agency, proposes a new rule to improve implementation of the Patient Protection and Affordable Care Act. Under the CMS proposed rule:

• Improvements to payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation (HHS-RADV) programs are included
• 2027 user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs) are included
• Other notable provisions are listed within the Federal Register

HHS, through the Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC), announced progress made in executing on President Trump’s, Secretary Kennedy’s, and Deputy Secretary O’Neill’s directive to lower the cost of healthcare for all Americans by leveraging and coordinating the nation’s strategic advantages in technology, AI, and healthcare infrastructure. This press release highlights the top eight accomplishments for the first year under the Trump administration.

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Inside NIH

Extramural News

The following press releases are intended for the external research community:

• NIH Support for Early Stage Investigators in FYs 2024 and 2025 | Grants & Funding
• Planning an NIH Application involving Basic Experimental Studies with Humans (BESH)?

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Intramural News

The following press releases relate to research conducted at the NIH:

• NIH halts arm of clinical trial evaluating a potential stroke treatment | National Institutes of Health (NIH)
  • I made a post about this update on LinkedIn
• NIH scientists develop “digital twin” of eye cells to understand and treat age-related macular degeneration | National Institutes of Health (NIH)
• Cognitive speed training over weeks may delay the diagnosis of dementia over decades | National Institutes of Health (NIH)

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Other Policy News

The NIH issued the following policy notices:

• NOT-OD-26-038: Correction to Guidance on Salary Limitation for Grants and Cooperative Agreements FY 2026
• NOT-OD-26-040: NIH No Longer Requires Advanced Permission for Conference Grant Applications

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