By Patrick Cooney, for AMRC
FEDERAL AGENCY NEWS
NIH Guidance During the Federal Government Shutdown
As of October 1, 2025, the lapse in federal appropriations has affected normal operations at the National Institutes of Health (NIH). The NIH issued guidance on its operations during the shutdown.
During this period, NIH staff will be unavailable to provide oversight or administrative support. However, institutions with active NIH awards may continue drawing funds through the Department of Health and Human Services’ (HHS) Payment Management System (PMS), which remains operational. Updates will be available at www.grants.nih.gov and www.hhs.gov.
The guidance indicates that applicants should continue submitting grant applications according to published deadlines, as both Grants.gov and NIH’s ASSIST system will accept submissions during the lapse. However, NIH will not process or review applications until operations resume. All peer review and advisory council meetings will be postponed, and affected reviewers will be notified once normal operations restart.
Work under active NIH grants may continue, but new awards will not be issued until the funding lapse ends.
CDER Director Comments on Clinical Trial Reporting Gap
On September 26, 2025, the Food and Drug Administration (FDA) published an article by George Tidmarsh, M.D., Ph.D., Director, Center for Drug Evaluation and Research (CDER). In the article, he emphasizes the importance of closing the “clinical trial reporting gap” to bolster research integrity and public trust, arguing that transparent and timely disclosure of trial results is both an ethical obligation and a scientific necessity. The agency highlights that, even after the 2017 Food and Drug Administration Amendments Act of 2007 (FDAAA) Final Rule, which requires certain trials to register and report results on ClinicalTrials.gov, many sponsors still fail to comply, with a particular lag among academic medical centers compared to industry. To address this, the FDA encourages institutions to centralize resources, improve training and accountability, and proactively support researchers in meeting disclosure obligations—and states it will continue holding parties accountable for noncompliance.
FDA Seeks Comment on E20 Guidance for Clinical Trials
On September 30, 2025, the Food and Drug Administration (FDA) announced the availability of a draft guidance for industry entitled “E20 Adaptive Designs for Clinical Trials.” The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Comments on the guidance are due by December 1, 2025.
The FDA draft guidance “E20 Adaptive Designs for Clinical Trials” (June 2025) outlines international harmonized principles for using adaptive designs in confirmatory clinical trials. It defines adaptive designs as trials that allow prospectively planned modifications—such as adjusting sample size, population, or treatment arms—based on interim data. The document aims to ensure such flexibility does not compromise scientific validity or regulatory standards. It stresses that adaptive designs can enhance efficiency, ethics, and decision-making by allowing earlier stopping or dose selection, but they also raise concerns over statistical bias, trial integrity, and the risk of erroneous conclusions if not properly pre-specified and analyzed.
The guidance identifies key principles to safeguard reliability and interpretability, including:
(1) ensuring adequacy within the overall development program,
(2) rigorous planning and justification of adaptations,
(3) controlling false-positive (Type I) and false-negative errors,
(4) ensuring unbiased estimation of treatment effects,
(5) maintaining trial integrity through confidentiality, independent data monitoring committees (IDMCs), and limited access to unblinded data.
It also provides detailed discussions of major adaptation types—early stopping, sample-size adjustments, population or treatment selection, and adaptive randomization—each requiring specific statistical safeguards to preserve validity and prevent operational bias.
Finally, the guideline includes special considerations for data monitoring, simulation studies, Bayesian approaches, and time-to-event endpoints. It emphasizes that adaptive designs should be pre-planned, justified through robust simulations, and reviewed with regulators before implementation. When Bayesian methods are proposed, sponsors must demonstrate that priors, external data, and decision criteria are appropriate and do not inflate false-positive risks. Overall, the E20 draft seeks to harmonize regulatory expectations globally and promote scientifically rigorous adaptive trials that accelerate drug development while maintaining credibility and patient safety.
HHS Announces CDC Updates to Immunization Schedules
On October 6, 2025, the Centers for Disease Control and Prevention (CDC) updated its adult and child immunization schedules to apply individual-based decision-making to COVID-19 vaccination and recommend that toddlers receive protection from varicella (chickenpox) as a standalone immunization rather than in combination with measles, mumps, and rubella vaccination. The immunization schedules adopt recent recommendations by the CDC Advisory Committee on Immunization Practices (ACIP), which were approved last week by Acting Director of the CDC and Deputy Secretary of Health and Human Services Jim O’Neill.
CAPITOL HILL NEWS
House Appropriations Committee to Act on FY26 Funding for Clinical Research
The federal government shutdown, which began on October 1, 2025, persists into its second week. A federal government shutdown occurs when Congress fails to pass appropriations bills or a continuing resolution to fund federal agencies and programs. During a shutdown, many government functions are suspended, and “non-essential” federal employees are furloughed, while those considered “essential” — such as public safety, national security, and certain health operations — continue to work without pay until funding resumes.
The immediate impact on health policy is largely administrative but can become significant if a shutdown persists. Research funding from the National Institutes of Health (NIH) and grant processing from the Health Resources and Services Administration (HRSA) and the Centers for Disease Control (CDC) may be delayed, impacting ongoing projects and new awards. Public health surveillance, regulatory reviews, and enforcement activities at FDA may slow, affecting the approval and oversight of drugs, devices, and biologics. The Center for Medicare and Medicaid Services (CMS) typically maintains core functions—such as Medicare and Medicaid payments—since they are mandatory spending, but new policy initiatives, pilot programs, and stakeholder engagement often pause. Longer-term shutdowns can reshape the federal health policy agenda by compressing timelines and shifting political leverage.
