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!
330+ subscribers and counting!
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 FDA
The FDA began accepting requests to participate in the FDA PreCheck pilot program.
- FDA PreCheck is designed to:
- Strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability, facilitating the construction of manufacturing sites in the U.S., and
- Streamline aspects of pharmaceutical manufacturing facility assessments in advance of a specific product application
- Phase I of the program will select participants who are developing new pharmaceutical manufacturing facilities based on alignment to program priorities
- Interested companies can review eligibility criteria, selection criteria, submission details, and what to expect through program participation
The Quality Management System Regulation (QMSR) became effective on February 2, 2026. Under QSMR:
- The device current good manufacturing practice (CGMP) requirements of 21 CFR Part 820 was amended
- Incorporated by reference the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices โ Quality management systems โ Requirements for regulatory purposes
This action harmonizes the FDAโs CGMP regulatory framework with that used by other regulatory authorities. You can read more about this update in a previous blog post: Recent HHS Family of Agencies Developments: Key Regulatory Changes and Research Implications.
The FDA created the Rare Disease Innovation Hub with the goal of ultimately improving outcomes for patients. This is a collaboration between Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER).
The U.S. Government Accountability Office (GAO) was absolutely obsessed with the FDA this week. In this Q&A blog post, GAO uncovers challenges for the FDA including becoming responsible for overseeing new types of products, including regulating all products containing nicotine (not just tobacco), as well as over-the-counter hearing aids. Next, the GAO issued the following reports:
- FDA: Oversight Responsibilities and Funding from Fiscal Years 2008 through 2024
- Rare Diseases: Funding for Rare Neurodegenerative Disease Research and Access to ALS Investigational Drugs
The FDA also released the following guidance documents:
- Computer Software Assurance for Production and Quality Management System Software (Final)
- Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions (Final)
- This has been reissued to align with FDA’s QMSR (1).
- E22 General Considerations for Patient Preference Studies (Draft)
- Available for public comment via Federal Register (2).
Lastly, the FDA issued a rule and notice via the Federal Register:
- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address (Rule)
- Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments (Notice)
Inside HHS
Per the Office of Management and Budget’s (OMB) memo on January 30th, HHS was affected by the shutdown. Luckily, only five days later OMB issued another memo that all agencies can resume operations on February 4th. Appropriations are available for the fiscal year ending September 30, 2026.
Inside NIH
Due to lapse in Federal funding, NIH announced that staff may not be available to provide oversight and administrative services. NIH hasn’t published a policy notice regarding resumption of operations. However, they did issue the following notice:
Finally, the NIH launched a new central resource to support replication and reproducibility. This centralized hub will highlight NIHโs ongoing efforts to promote rigorous, transparent, and reliable science. he new resource:
- Outlines NIHโs current activities and future directions to support replication studies,
- Incentivizes reproducible research practices, and
- Embeds these principles more fully across the biomedical research ecosystem.
I hope you found this bite-size weekly update helpful!
Leave a Reply