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Authored By: Tasha Mohseni
It can be difficult to keep up with it all policy changes that occurred in calendar year (CY) 2025.
Therefore, in this three-part blog series, I will cover significant policy changes from the following agencies:
- Department of Human and Health Services (HHS) and select agencies including:
- Office of Research Integrity (ORI)
- Food and Drug Administration (FDA)
- National Institutes of Health (NIH)
- National Science Foundation (NSF)
- Department of Energy (DOE)
- Department of Defense (DoD) (or Department of War (DOW))
- Department of Education (ED)
- Office of Science and Technology Policy (OSTP)
- Office of Management and Budget (OMB)
- Executive Orders from the White House
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:
HHS CY25 Updates (Select Press Releases)
- Statement from Dr. Dorothy Fink, Acting Secretary of the U.S. Department of Health and Human Services
- Robert F. Kennedy, Jr. Sworn in as 26th Secretary at HHS, President Trump Signs Executive Order to Make America Healthy Again
- President Donald J. Trump Nominates Individuals to Key Posts at the Department of Health and Human Services
- HHS Office of General Counsel Announces Reorganization Effort
- HHS Announces Transformation to Make America Healthy Again
- HHS Secretary Kennedy to Hold Press Conference on Latest CDC Data Showing Alarming Increase of Autism Epidemic
- HHS, NIH Launch Next-Generation Universal Vaccine Platform for Pandemic-Prone Viruses
- Administration for Community Living Grant Award and Funding Opportunity
- NIH, CMS Partner to Advance Understanding of Autism Through Secure Access to Select Medicare and Medicaid Data
- HHS, FDA Issue RFI on Deregulatory Plan to Lower Costs and Empower Providers
- Secretary Kennedy to World Health Assembly: The United States Is Holding the World Health Organization (WHO) Accountable
- HHS, CMS Set Most-Favored-Nation Pricing Targets to End Global Freeloading on American Patients
- HHS Takes Bold Step to Restore Public Trust in Vaccines by Reconstituting ACIP
- DOJ-HHS False Claims Act Working Group
- ARPA-H Launches Program to Restore Brain Function and Return Patients to Independence
- CMS Expands Access to Lifesaving Gene Therapies Through Innovative State Agreements
- Joint Statement by Secretary of Health and Human Services Robert F. Kennedy, Jr. and Secretary of State Marco Rubio on International Health Regulations Amendments
- HHS & State Department: The United States Rejects Amendments to International Health Regulations
- HHS Finds Systemic Disregard for Sanctity of Life in Organ Transplant System
- HHS Adopts ACIP Recommendation to Remove Thimerosal from All U.S. Influenza Vaccines
- Secretary Kennedy, Deputy Secretary OโNeill, Commissioner Makary, and U.S. Senator Mullin to Host Press Conference on Measures to Safeguard American Public from Dangerous Opioid 7-OH
- HHS Announces $100M in Pilot Funding Opportunity to Eliminate Hepatitis C
- Living HHS Open Data Plan Published, HealthData.gov Refreshed to Provide Greater Transparency, Encourage Innovation, and Eliminate Information Silos
- HHS, CMS Eliminate Financial Pressure Tied to Hospital Staff Vaccination Reporting
- FDA Names Top HHS Lawyer as Chief Counsel
- HHS Winds Down mRNA Vaccine Development Under BARDA
- Statement from the U.S. Department of Health and Human Services
- HHS Revives Task Force on Safer Childhood Vaccines
- HHS Expands Oversight of Organ Transplant System with New Surveillance Tool
- SAMHSA Announces $19M in Supplemental Funding to Strengthen Housing Capacity for Homeless People with Serious Mental Illness
- RFK Jr.: Weโre Restoring Public Trust in the CDC
- Americans to Gain New Access to Real-Time Prescription Drug Price Information
- HHS Announces Crackdown on Health Data Blocking
- HHS Expands Access to Affordable Health Insurance
- MAHA Commission Unveils Sweeping Strategy to Make Our Children Healthy Again
- HHS, FDA to Require Full Safety Disclosures in Drug Ads
- HHS, CDC Announce New ACIP Members
- ACIP Recommends Standalone Chickenpox Vaccination in Toddlers
- ACIP Recommends COVID-19 Immunization Based on Individual Decision-making
- HHS Provides More Than $1.5 Billion in State and Tribal Opioid Response Grants
- SAMHSA Awards More Than $45 Million in Supplemental Funding to Support Young Adult Sober Housing Services
- Administration for Community Living Awards $60 Million to Advance Make America Healthy Again Agenda
- HHS Doubles AI-Backed Childhood Cancer Research Funding
- CDC Immunization Schedule Adopts Individual-Based Decision-Making for COVID-19 and Standalone Vaccination for Chickenpox in Toddlers
- CMS Announces New Drug Payment Model to Strengthen Medicaid and Better Serve Vulnerable Americans
- HHS Backs AI Innovation for Americaโs Caregivers
- CMS Empowers Patients and Boosts Transparency by Modernizing Hospital Payments
- Renowned Epidemiologist and Biostatistician Martin Kulldorff Appointed to Senior HHS Role
- HHS Unveils AI Strategy to Transform Agency Operations
- ACIP Recommends Individual-Based Decision-Making for Hepatitis B Vaccine for Infants Born to Women Who Test Negative for the Virus
- Secretary Kennedy Swears in Louisiana Surgeon General Ralph Abraham as Principal Deputy Director of CDC
- Dr. Harvey Risch Appointed Chairman of President Trumpโs Cancer Panel
- CDC Adopts Individual-Based Decision-Making for Hepatitis B Immunization for Infants Born to Women Who Test Negative for the Hepatitis B Virus
- HHS Announces Request for Information to Harness Artificial Intelligence to Deflate Health Care Costs and Make America Healthy Again
- HHS Proposes HTI-5 Rule to Streamline Certification Program, Further Protect Patients from Information Blocking, and Foster an Artificial Intelligence-enabled Future
FDA CY25 Updates
Select Guidance Documents
- Considerations for Complying with 21 CFR 211.110
- Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act
- Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers
- Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act
- Developing Drugs for Optical Imaging
- Considerations for Including Tissue Biopsies in Clinical Trials
- Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products: Draft Guidance for Industry and Other Interested Parties
- Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway
- Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff
- Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff
- Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act: Guidance for Industry and Food and Drug Administration Staff
- Premarket Approval Application and Humanitarian Device Exemption Modular Review: Guidance for Industry and FDA Staff
- Evaluation of Sex Differences in Clinical Investigations: Guidance for Industry
- Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs
- Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators
- Data Standards Catalog
- Evaluation of Sex-Specific Data in Medical Device Clinical Studies – Guidance for Industry and Food and Drug Administration Staff
- Electronic Submission Template for Medical Device Q-Submissions: Draft Guidance for Industry and Food and Drug Administration Staff
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: – Final Guidance for Industry and Food and Drug Administration Staff
- M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver: Draft Guidance for Industry
- Transfer of a Premarket Notification (510(k)) Clearance โ Questions and Answers: Draft Guidance for Industry and Food and Drug Administration Staff
- M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)
- M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol
- Post-Warning Letter Meetings Under GDUFA
- Q1 Stability Testing of Drug Substances and Drug Products: Draft Guidance for Industry
- Conducting Remote Regulatory Assessments Questions and Answers: Guidance for Industry
- Unique Device Identifier Requirements for Combination Products: Draft Guidance for Industry
- Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff
- Approaches to Assessment of Overall Survival in Oncology Clinical Trials: Draft Guidance for Industry
- Withdrawn Guidances (Biologics)
- Classification Categories for Certain Supplements Under BsUFA III
- E6(R3) Good Clinical Practice (GCP)
- Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry
- Safety Labeling ChangesโImplementation of Section 505(o)(4) of the FD&C Act: Draft Guidance for Industry
- Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations: Draft Guidance for Industry
- Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products: Draft Guidance for Industry
- Expedited Programs for Regenerative Medicine Therapies for Serious Conditions: Draft Guidance for Industry
- E20 Adaptive Designs for Clinical Trials
- Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
- Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
- Quality Management System Information for Certain Premarket Submission Reviews: Draft Guidance for Industry and Food and Drug Administration Staff
- Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies: Draft Guidance for Industry
- How to Prepare a Pre-Request for Designation (Pre-RFD): Guidance for Industry
- Cross-Center Master Files: Where to Submit: Draft Guidance for Industry
- Q3E Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable Monographs
- Q3E Guideline for Extractables and Leachables
- Medical Gases โ Current Good Manufacturing Practice: Draft Guidance for Industry
- Monoclonal Antibodies: Streamlined Nonclinical Safety Studies: Draft Guidance for Industry
- QTc Information in Human Prescription Drug and Biological Product Labeling: Guidance for Industry
- eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff
- Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers: Guidance for Industry
- Enhancing Participation in Clinical Trials โ Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry
- Study of Sex Differences in the Clinical Evaluation of Medical Products
- Investigator Responsibilities โ Safety Reporting for Investigational Drugs and Devices: Guidance for Industry
- Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies: Guidance for Industry
- Study Data Technical Conformance Guide – Technical Specifications Document
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff
- Processes and Practices Applicable to Bioresearch Monitoring Inspections: Guidance for Industry
- Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act
Guidance Snapshot Pilot Documents
Press Releases
- – FDA Roundup: January 3, 2025
- – FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices
- – FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions
- – FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials
- – FDA Roundup: January 7, 2025
- – FDA Roundup: January 10, 2025
- – FDA Roundup: January 14, 2025
- – FDA Roundup: January 17, 2025
- – FDA Roundup: February 28, 2025
- – FDA Roundup: March 4, 2025
- – FDA Roundup: March 7, 2025
- – FDA Roundup: March 11, 2025
- – FDA Roundup: March 14, 2025
- – FDA Roundup: March 18, 2025
- – FDA Roundup: March 21, 2025
- – FDA Roundup: March 28, 2025
- – Martin A. Makary, M.D., M.P.H., Sworn in as FDA Commissioner
- – FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs
- – FDA Commissioner Makary Announces New Policy on Individuals Serving on FDA Advisory Committees
- – FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline
- – FDA and NIH Announce Innovative Joint Nutrition Regulatory Science Program
- – HHS, FDA Issue RFI on Deregulatory Plan to Lower Costs and Empower Providers
- – FDA to Host Inaugural, Independent, Scientific Expert Panel Open to Public
- – FDA takes steps to enhance state importation programs to help lower prescription drug prices
- – FDA Takes Action to Address Data Integrity Concerns with Two Chinese Third-Party Testing Firms
- – FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People
- – FDA to Issue New Commissionerโs National Priority Vouchers to Companies Supporting U.S. National Interests
- – FDA Halts New Clinical Trials That Export Americansโ Cells to Foreign Labs in Hostile Countries for Genetic Engineering
- – FDA Embraces Radical Transparency by Publishing Complete Response Letters
- – FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys and Places Clinical Trials on Hold for Multiple Gene Therapy Products Following 3 Deaths
- – Stanford faculty member George Tidmarsh, M.D., Ph.D. named Director of Center for Drug Evaluation and Research
- – FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers
- – FDA Names Top HHS Lawyer as Chief Counsel
- – FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing
- – Statement from FDA Commissioner Marty Makary, M.D., M.P.H., on Florida Restriction of 7-OH Opioid Products
- – FDA Begins Real-Time Reporting of Adverse Event Data
- – FDA Advances Rare Disease Drug Development with New Evidence Principles
- – FDA Announces Real-Time Release of Complete Response Letters, Posts Previously Unpublished Batch of 89
- – FDA Launches Green List to Protect Americans from Illegal Imported GLP-1 Drug Ingredients
- – FDA Launches Crackdown on Deceptive Drug Advertising
- – FDA Issues New Guidance to Expand Non-Opioid Options for Chronic Pain, Curb Misuse
- – FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During Pregnancy
- – FDA Takes Action to Make a Treatment Available for Autism Symptoms
- – FDA Awards First-Ever National Priority Vouchers to Nine Sponsors
- – FDA Publishes Filing Checklists to Prevent Submission Delays
- – FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs
- – FDA Awards Second Batch of National Priority Vouchers
- – HHS Advances Womenโs Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy
- – Longtime FDA Innovator Appointed as Director of Center for Drug Evaluation and Research
- – FDA Pilots Faster Clarifications to Meeting Minutes
- – FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment
- – FDA Seizes 7-OH Opioids to Protect American Consumers
- – FDA Releases Draft Guidance on Reducing Testing on Non-Human Primates for Monoclonal Antibodies
- – FDA Launches TEMPO: A First-of-Its-Kind Digital Health Pilot to Expand Access to Chronic Disease Technologies
- – First Approval in Commissioner’s National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity
- – FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews
- – FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study Results
- – FDA Grants Two National Priority Vouchers
- – FDA Explores New Contracting Approach to Advance Public Health Innovation
FDA Voices
- CDER Brings Many Safe and Effective Therapies to Patients and Consumers in 2024
- FDA Advances Drug Development Innovation by Establishing ISTAND as Permanent Qualification Program
- FDA Focuses on Closing the Clinical Trial Reporting Gap for Research Integrity
- FDA Encourages Development of New, Reliable Alternatives to Animal Testing in Sunscreen
NIH CY25 Updates
NIH-wide Policy Notices
- RESCINDED – NIH Implementation of the U.S. Government Policy for Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP): NOT-OD-25-061
- NIH Implementation of Uniform Administrative Requirements for Federal Financial Assistance: NOT-OD-25-059
- RESCINDED – Notice of Civil Rights Term and Condition of Award: NOT-OD-25-090
- Reminder: Application Requirements for Projects Involving Activities Outside of the United States or Partnerships with International Collaborators: NOT-OD-25-098
- Revision: Notice of Updated Effective Date for the 2024 NIH Public Access Policy: NOT-OD-25-101
- Updated NIH Policy on Foreign Subawards: NOT-OD-25-104
- Updated NIH Processes for No-Cost Extensions: NOT-OD-25-110
- Implementation Update: Improving the Safety and Security of Biological Research: NOT-OD-25-112
- Request for Information on Responsibly Developing and Sharing Generative Artificial Intelligence Tools Using NIH Controlled Access Data: NOT-OD-25-118
- Notice of Rescission of Civil Rights Term and Condition of Award: NOT-OD-25-124
- Implementation Update: Terminating or Suspending Dangerous Gain-of-Function Research in Accordance with the Executive Order on Improving the Safety and Security of Biological Research: NOT-OD-25-127
- Guidance on Enforcement of Closeout Requirements During the Appeals Process: NOT-OD-25-128
- NIH Announces a New Policy Requirement to Train Senior/Key Personnel on Other Support Disclosure Requirements: NOT-OD-25-133
- Supporting Fairness and Originality in NIH Research Applications: NOT-OD-25-132
- Flexibilities for Registration and Results Reporting of Prospective Basic Experimental Studies with Human Participants: NOT-OD-25-134
- Revision: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research: NOT-OD-25-131
- Updated Implementation Guidance of NIH Policy on Foreign Subawards for Active Projects: NOT-OD-25-130
- Request for Information on Maximizing Research Funds by Limiting Allowable Publishing Costs: NOT-OD-25-139
- Update: No-Cost Extension Functionality in eRA: NOT-OD-25-142
- NIH Will Stop Posting Notices of Funding Opportunities in the NIH Guide for Grants and Contracts in FY2026: NOT-OD-25-143
- Review of the Accuracy of Grants Information for Fiscal Year 2025: NOT-OD-25-151
- Preview of NIH Common Forms for Biographical Sketch and Current and Pending (Other) Support Coming Soon to SciENcv: NOT-OD-25-152
- RESCINDED – Implementation of NIH Research Security Policies: NOT-OD-25-154
- New Application Structure for NIH-Funded International Collaborations: NOT-OD-25-155
- NIH Disposition of Biospecimens Collected from Tribal Populations: NOT-OD-25-153
- Required Security and Operational Standards for NIH Controlled-Access Data Repositories: NOT-OD-25-159
- NIH Policy on Enhancing Security Measures for Human Biospecimens: NOT-OD-25-160
- Updated NIH Policy on Allowable Costs for Animals: NOT-OD-25-163
- Update: Recission Notice re: Implementation of NIH Research Security Policies: NOT-OD-25-161
- Reminder of Compliance Requirements for NIH Extramural Recipients Related to Renegotiated Aims, Objectives, Titles, and Abstracts: NOT-OD-26-007
- Updated Terms and Conditions of Award Termination and Compliance with Court Orders: NOT-OD-26-009
- Research Security Training Requirements for NIH: NOT-OD-26-017
- NIHs Implementation of Common Forms for Biographical Sketch and Current and Pending (Other) Support for Due Dates on or after January 25, 2026: NOT-OD-26-018
- Updated Application Policies: NIH Administrative Burden Reduction Effort Removal of Requirements for Letters of Intent and Unsolicited Applications Requesting $500,000 or More in Direct Costs: NOT-OD-26-019
- Request for Information on Draft NIH Controlled-Access Data Policy and Proposed Revisions to NIH Genomic Data Sharing Policy: NOT-OD-26-023
- Reminder: NIH Applications Must Be Complete and Compliant with NIH Policy and Application Instructions at Time of Submission: NOT-OD-26-025
Extramural News
- What Should a Researcher Know If Their Animal Study May Involve Another Institution?
- How Does NIH Determine Early Stage Investigator Eligibility?
- Information forโฆYou! Curated Resources by Role
- To Do in 2025: Keep Your eRA Personal Profile Updated
- Away For a Bit? Delegate Your Tasks in eRA Commons
- Explore a Typical NIH Funding Opportunity
- Reviewer Guidance for the Simplified Review Framework
- Find NIH Funding Information More Quickly and Easily with RCDCโs New Look and Feel
- How Can You Effectively Prepare NIH Research Project Grant Applications for Due Dates in 2025 and Beyond?
- Implementation of New Initiatives and Policies Page Now Available
- New Home for Extramural Nexus on the NIH Grants and Funding Website
- Reminder: Application Requirements for Projects Involving Activities Outside of the United States or Partnerships with International Collaborators
- Accelerating Implementation of the NIH 2024 Public Access Policy
- New NIH Foreign Subaward Structure Enhances Integrity, Accountability, Oversight, and National Security of NIH Funded Research
- How Are Childcare Costs Issued to Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Awards?
- Reminder About Inclusion of Participants in Clinical Research
- Automatic Extension of Early Stage Investigator Status to Address Recent Delays
- Protecting Human Genomic Data When Developing Generative Artificial Intelligence Tools and Applications
- If You See Something Amiss, Say Something
- Why Did NIH Expire Some Funding Opportunities Because of the Simplified Review Framework, and What Does It Mean for My Application?
- Announcing the NIH Autism Data Science Initiative Research Opportunity
- What’s the Difference Between “Frozen” and “Current” Data in RePORT?
- NIH is Temporarily Extending Eligibility for Some Mentored Career Development Awards
- My First Substantial Independent Research Award Was Terminated Early. Can My ESI Status Be Reinstated?
- New FY 2024 NIH Categorical Spending Data Available, Including an Updated Womenโs Health Research Category to Improve Accuracy and Consistency
- New Home for Research Training and Career Development Information on the NIH Grants and Funding Website
- Check Out These Public Federal Funding Databases to Learn More About Funding at NIH and Other Federal Agencies
- Progress on Implementation of the Simplified Review Framework
- Introducing the 2025-2030 NIH Strategic Plan for Data Science: What Researchers Need to Know
- New NIH Public Access Pages to Support the 2024 NIH Public Access Policy
- NIH Extramural Loan Repayment Programs Guide Notices Available
- Upcoming Changes to Extramural Nexus Email Delivery
- NIH Funding Announcements to Align with NIH Initiative to Prioritize Human-based Research
- NIH Fellowship Funding Opportunities Are Here
- How Does the NIH Initiative to Prioritize Human-Based Research Affect Research Proposing the Use of Laboratory Animals?
- Short-Term Supplement Model for Human Subjects Research Supported by Foreign Subawards
- Flexibilities for Registration and Results Reporting of Prospective Basic Experimental Studies with Human Participants
- Apply Responsibly: Policy on AI Use in NIH Research Applications and Limiting Submissions per PI
- Share Your Feedback on Maximizing Research Funds by Limiting Allowable Publication Costs
- Weโve Moved: The NIH Scientific Data Sharing Pages are Now on the NIH Grants & Funding Site
- Updates to NIH Inclusion Policy
- NIH Extramural Loan Repayment Programs: Application Cycle Opening and New Website Location
- Introducing Highlighted Topics: A Centralized and Simple Resource to Learn About Research Areas of Interest to NIH
- No-Cost Extension Functionality Re-Enabled
- Certificate of Confidentiality (CoC) System Is Accepting Requests
- Reminder to Review Accuracy of Grant Information Before October 6, 2025
- Announcing New Application and Award Structure for NIH-Funded International Collaborations (Replacing Foreign Subawards)
- Dr. Jon Lorsch Named NIH Deputy Director for Extramural Research
- Applying for a NIH Loan Repayment Program (LRP) Award? Donโt Miss the Upcoming Webinar!
- Highlighted Topics Resource Round-Up
- New Tool to Explore NIH Grant Opportunities
- Standardized Organoid Modeling Center to Reduce Reliance on Animal Modeling
- Implementing a Unified NIH Funding Strategy to Guide Consistent and Clearer Award Decisions
- Emergency Modifications to NIH Peer Review
- What Are the Differences Between Highlighted Topics and Funding Opportunities?
- Updated NIH Fellowship Resources Are Available
- NIH Issues Request for Information on Draft Proposal Harmonizing Research Participant Data Policies
- What if I Forgot to Include a Required Attachment of an Application?
- Accelerating Research, Cutting Red Tape: 2025 at NIH
Director Statements
- NIH Reviews Policies to Promote Academic Freedom
- Accelerating Access to Research Results: New Implementation Date for the 2024 NIH Public Access Policy
- NIH to update policies and practices guiding subawards
- FDA halts new clinical trials that export Americansโ cells to foreign labs in hostile countries for genetic engineering
- NIH to Establish New Policies for Allowable Publication Costs
- Statement on the retirement of Dr. Noni Byrnes
- Advancing NIHโs Mission Through a Unified Strategy
- NIH Publishes Plan to Drive Gold Standard Science
- Maximizing and Safeguarding NIHโs Investment in Foreign Collaborations
- Leading By Example: Embedding Principles of Academic Freedom at NIH
- NIH Launches Initiative to Modernize and Strengthen Biosafety Oversight
- Statement on the Departure of Dr. Nina Schor
- Statement on Dr. Jon Lorsch Being Named NIH Deputy Director for Extramural Research
- Statement on the Retirement of NCCIH Director Dr. Helene Langevin
- Statement on the Selection of Dr. Rick Woychik as Senior Advisor to the NIH Director for the โMake America Healthy Againโ Strategy
- Roadmap for Engaging the Public as Partners in Clinical Research
Select Intramural News
- NIH researchers discover novel class of anti-malaria antibodies
- NIH-funded study finds cases of ME/CFS increase following SARS-CoV-2
- NIH to lead implementation of National Plan to End Parkinsonโs Act
- NIH study finds infection-related hospitalizations linked to increased risk of heart failure
- NIH-funded clinical trial will evaluate new dengue therapeutic
- NIH-funded research team engineers new drug targeting pain sensation pathway
- NIH centralizes peer review to improve efficiency and strengthen integrity
- Topical steroid withdrawal diagnostic criteria defined by NIH researchers
- NIH-sponsored trial of Lassa vaccine opens
- NIH-funded study identifies potential new stroke treatment
- NIH researchers develop eye drops that slow vision loss in animals
- Jay Bhattacharya Begins Tenure as 18th Director of the National Institutes of Health
- AI screening for opioid use disorder associated with fewer hospital readmissions
- Annual Report to the Nation: Cancer deaths continue to decline
- NIH researchers supercharge ordinary clinical device to get a better look at the back of the eye
- NIH study reveals how inflammation makes touch painful
- NIH to prioritize human-based research technologies
- HHS, NIH launch next-generation universal vaccine platform for pandemic-prone viruses
- NIH, CMS Partner to Advance Understanding of Autism Through Secure Access to Select Medicare and Medicaid Data
- FDA and NIH announce innovative joint Nutrition Regulatory Science Program
- NIH researchers discover tissue biomarker that may indicate higher risk of aggressive breast cancer development and death
- NIH to Fund Long-Term Health Studies for East Palestine After Train Disaster
- NIH to crack down on excessive publisher fees for publicly funded research
- NIH researchers develop AI agent that improves accuracy of gene set analysis by leveraging expert-curated databases
- NIH scientists lay foundation for potential gene-editing therapy for late-onset Tay-Sachs
- NIH launches consortium to reduce risk of stillbirth in the U.S.
- NIH launches $50M Autism Data Science Initiative to unlock causes and improve outcomes
- NIH establishes nation’s first dedicated organoid development center to reduce reliance on animal modeling
- Secretary Kennedy Swears in Dr. Anthony Letai as Director of the National Cancer Institute
- HHS Doubles AI-Backed Childhood Cancer Research Funding
- Dr. Kyle Walsh selected to lead the National Institute of Environmental Health Sciences
- NIH-led study reveals role of mobile DNA elements in lung cancer progression
ORI CY25 Updates
- Research Misconduct Finding: Liping Zhang
- 2025 National Conference on Research Integrity
- Notice of Funding Opportunity Technical Assistance Webinar
- Sample Policy & Procedures for Responding to Research Misconduct Allegations
- ORI’s First Phase of Final Rule Guidance Documents Released
- ORI Announces 3 Funding Opportunities!
- Notice of Funding Opportunity Technical Assistance Webinar Materials
- Research Misconduct Finding: Ryan Evanoff
- ORI’s Second Phase of Guidance Documents Released
- New ORI Final Rule Guidance Documents Released
- ORI Announces the Release of the 2024 Annual Report
I hope you found Part 1 of this CY25 Federal agency update resourceful!
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