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.
Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!
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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:
Updates Since Last Week’s Edition
This section contains updates that became available AFTER the prior week’s edition was published:
- FDA CDER
- FDA CDRH
- Emergency Response Safety Kit Recall: Airlife Removes Certain Broselow Pediatric Emergency Rainbow Tapes and Broselow ALS Organizers
- Electronic Homecare Bed Correction: Medline Updates Use Instructions for Homecare Beds
- Medical Device Supply Chain Vulnerabilities and the Public Health Impact They Have on Our Most Vulnerable Patients
- Though this statement was released last month, CREST recently became aware of CDRH statements
- HHS ASTP
- TEFCAโข, Americaโs National Interoperability Network, Reaches Nearly 500 Million Health Records Exchanged as HHS Leverages Technology and AI to Lower Costs and Reduce Burden
- Data Liquidity, Affordability, and Access: The History & Growth of TEFCAโข (Fact Sheet)
- ASTP Annual Meeting Recordings and Slides
Inside FDA
The FDA’s Office of Inspections and Investigations published the following rules which revoke specific regulations:
- Revocation of Methods of Analysis Regulation
- Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community
Inside CDER
Review CDER’s drug approvals below:
CDER issued the following notice to the Federal Register:
Finally, CDER issued a warning letter to Dr. Cole for his role as s clinical investigator. The investigator didn’t adhere to the protocol.,The deviation related to incorrect dosing for four out of four participants during various site visits. These significant dosing errors led to adverse events, including nausea, vomiting, stomach pain, fatigue, dizziness, pyrosis (heartburn), and injection-site reactions.
Inside CDRH
On March 11, 2026, CDRH will host a town hall to discuss updates to the Clinical Decision Support Software, Final Guidance, issued on January 6, 2026, and re-issued on January 29, 2026.
- Curious about the differences between the two document versions? You can read my brief analysis on LinkedIn.
The FDA is aware that Trividia Health, Inc. has issued an Urgent Medical Device Correction to notify affected customers that all TRUE METRIX, TRUE METRIX AIR, and TRUE METRIX GO Self-Monitoring and TRUE METRIX PRO Professional Monitoring Blood Glucose Systems have updated use instructions. This early alert details the specific affected devices as well as next steps.
CDRH issued the following notice in the Federal Register:
Inside CBER
The following biologics have received FDA approval:
The FDA and the University of Texas Medical Branch are launching an in-person and virtual Non-Clinical Course. This four and one-half day training program is offered annually utilizing expert faculty from the not only the FDA, but also other government agencies, academia, and business and industry. In-person attendees participate in laboratory activities conducted in mock Biosafety Level (BSL) 2, 3, and 4 training laboratories to emphasize the differences between biosafety levels and the complexity of conducting laboratory activities in a BSL4 laboratory environment.
Inside HHS
HHS issued the following RFI in the Federal Register:
The GAO issued the High Risk Research: HHS Should Publicly Share More Information on How Risk Is Assessed and Mitigated report. GAO found that HHS doesn’t consistently disclose important details about its process for weighing the risks and benefits of this research or reveal how many projects involve these potentially dangerous pathogens. There was only one recommendation:
“The Secretary of Health and Human Services should work with HHS funding agencies to ensure that key information on the agencies’ risk reviews of extramural research and intramural projects involving pathogens are publicly shared with researchers, Congress, and the public, as appropriate. Such information should be regularly updated and include the outcomes of risk reviews, steps HHS funding agencies and researchers took to mitigate risk, and the total number of research projects involving higher-risk pathogen research that agencies support.”
Inside NIH
Extramural News
The following press releases are intended for the external research community:
- Stay Informed About NIH Grants Policy and Processes
- Learn How Much You Could Receive for a Loan Repayment Award
Intramural News
- No updates for this section this week.
Other Policy News
The NIH issued the following policy notices:
I hope you found this bite-size weekly update helpful!
