Tag: science policy

Table of Contents

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Inside HHS

HHS reversed its action of re-organization by removing the Assistant Secretary for Technology Policy and restoring with the Office of the National Coordinator for Health Information Technology (ONC)¹,².

The Office of Research Integrity (ORI) has announced co-sponsorship opportunities with non-federal institutions. The purpose of these events is to advance research integrity across the scientific research enterprise³.

In other news:

• Advanced Research Projects Agency for Health (ARPA-H) announced STOMP: Systematic Targeting Of MicroPlastics, a nationwide $144 million program to create the definitive toolbox for measuring, researching, and affordably removing microplastics and nanoplastics (MNPs) in the human body⁴.
• HHS and EPA announced landmark, coordinated actions to address microplastics contamination, one of the most urgent and growing public health challenges facing Americans⁵.
• Administration for Children and Families (ACF) proposes to amend the Block Grants regulations, the Individual Development Account Reserve Funds Established Pursuant to Grants for Assets for Independence regulations, and the Emergency Community Services Homeless Grant Program regulations to eliminate unnecessary or obsolete regulations⁶.
• Health Resources and Services Administration (HRSA) announced more than $135 million in new funding opportunities to expand nutrition services and strengthen the rural health workforce⁷.
• HHS led a coordinated, cross-agency transition with the Federal Aviation Administration (FAA) and the Defense Finance and Accounting Service (DFAS) to move away from manual processes, overcoming limited documentation and decades-old logic to deliver a scalable, interoperable system⁸.
• HHS Secretary Robert F. Kennedy, Jr. traveled to Arizona as part of his “Take Back Your Health” tour, meeting with leaders across health care, independent living, and recovery to drive a prevention-focused agenda⁹.
• HHS announced the 2026 KidneyX EMPOWER Prize Challenge, a $4 million national competition to accelerate innovation supporting living kidney donors and patients who depend on them¹⁰.
• HHS announced the appointment of Casey B. Mulligan, PhD, as Chief Economist and Chief Regulatory Officer. Mulligan is a renowned University of Chicago economist who served as Chief Economist on the Council of Economic Advisers during the first Trump Administration¹¹.
• APRA-H announced the first set of research teams for its Evidence-Based Validation & Innovation for Rapid Therapeutics in Behavioral Health (EVIDENT) initiative, which will collectively fund up to $139.4 million to help spur new, effective therapies for behavioral health¹².
• ORI found that Ariel Fernandez, PhD (Respondent), former Karl F. Hasselmann Chaired Professor of Engineering, Department of Bioengineering, Rice, engaged in research misconduct under 42 CFR Part 93¹³.

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Inside FDA

FDA is working towards clearer recommendations for Real-World Evidence (RWE). RWE is the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of Real-World Data (RWD). FDA reported on 73 new examples growing use of RWD to validate device software functions, including artificial intelligence (AI)¹⁴,¹⁵.

The FDA reminded more than 2,200 medical product companies and researchers of the requirements to submit certain clinical trial results information to ClinicalTrials.gov. According to an internal analysis, 29.6% of studies that are highly likely to fall under mandatory reporting requirements have no results information submitted to ClinicalTrials.gov. The FDA also may send Pre-Notices of Noncompliance and Notices of Noncompliance as part of risk-based compliance efforts related to ClinicalTrials.gov¹⁶.

The FDA shared promising progress towards a new indication of Testosterone Replacement Therapy (TRT). Sponsors are encouraged to contact the FDA for information if they are interested in pursuing a potential new indication for low libido in men with idiopathic hypogonadism (without a known cause). This would require demonstration of substantial evidence of effectiveness and that the benefits outweigh the risks for the intended population¹⁷,¹⁸.

Starting October 1, 2026, postmarketing individual case safety reports (ICSRs) must be reported using the data standards adopted by FDA in the International Council for Harmonisation (ICH) guidance for industry entitled “E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide—Data Elements and Message Specification” (ICH E2B(R3) Implementation Guidance), which incorporates by reference regional implementation guides (collectively ICH E2B(R3) data standards)¹⁹.

The FDA achieved its key first-year goals in the implementation of its April 2025 Roadmap to Reducing Animal Testing in Preclinical Safety Studies which included:

• Releasing draft guidance on the reduction or elimination of nonhuman primate testing in monoclonal antibody development,
• Updating guidance to support a transition from horseshoe crab-derived endotoxin testing, which could spare more than one million animals per year,
• Working to reduce or eliminate animal used for FDA approval when drugs have demonstrated safety from their broad use in humans in other countries,
• Releasing draft guidance expanding the use of weight-of-evidence approaches to support the use of NAMs and other human-relevant models to generate evidence across a wider array of safety endpoints,
• Qualifying the first artificial intelligence-based drug development tool, and  
• Launching a searchable database clarifying where alternative methods are acceptable and established close collaboration with international regulators to align strategies²⁰. 

Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities. This conferences also offers tracks for 1:1 opportunities for questions. Topics covered include:

• Advanced Drug Manufacturing in CDER,
• Use of AI to Advance Drug Development,
• FDA’s Quality Management System Regulation (QMSR),
• Small Business Determination Program Updates,
• Use of Digital Health Technologies for Data Collection in Clinical Trials,
• Benefit-Risk Framework and Analytical Methods to Inform Benefit-Risk, and
• Much more²¹.

In other news:

• FDA issued eight rules related to medical devices and new animal drug applications²²,²³,²⁴,²⁵,²⁶,²⁷,²⁸,²⁹,³⁰,³¹,³².
• FDA issued a notice related to Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments³³.
• FDA issued the following guidance documents related to:
  • Bioanalytical Method Validation for Biomarkers³⁴,
  • Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing³⁵.³⁶,³⁷,
  • Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators³⁸,³⁹,
  • Establishing Impurity Specifications for Antibiotics⁴⁰,⁴¹,
  • Expanded Access⁴², and
  • Revision to ICH Guidance on Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing for Medicated Premixes⁴³.
• FDA approved Foundayo (orforglipron) making them the 5th approval under the Commissioner’s National Priority Voucher (CNPV) pilot program⁴⁴.
  • Relatedly, FDA approved Otarmeni (lunsotogene parvec-cwha), the first-ever dual adeno-associated virus (AAV) vector-based gene therapy marking this the 6th approval under the CNPV pilot program⁴⁵,⁴⁶.
• FDA updated four of their CBER Biological Procedures (SOPPs)⁴⁷,⁴⁸,⁴⁹,⁵⁰.
• FDA CDRH shared a plethora of updates including:
  • 510(k) Third Party Performance Report⁵¹,
  • READI-Home Innovation Challenge⁵²,
  • MedSun Newsletter⁵³,
  • Electronic Medical Device Reporting⁵⁴, and
  • MDUFA meeting minutes⁵⁵,⁵⁶.
• FDA and CMS announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, a new pathway designed to expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare⁵⁷.
• C3TI Compass is a knowledge repository that connects users to FDA guidance documents, case studies, and resources that support innovative approaches to clinical trial design and conduct. Compass centralizes completed activities, ongoing efforts, and practical tools to support engagement with CDER’s clinical trial innovation work and improve clinical trial efficiency⁵⁸.
• The FDA finally issued a Request for Information (RFI) regarding a proposed pilot program to assess how artificial intelligence (AI)-enabled technologies can improve efficiency, speed, and quality of decision-making in early phase clinical trials⁵⁹,⁶⁰.

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Inside NIH

Basic Experimental Studies with Humans (BESH) will no longer be subject to NIH clinical trial requirements (e.g. registration and reporting in ClinicalTrials.gov). However, BESH must continue to follow all other applicable laws, regulations, and policies (e.g., human subjects protections and the Data Management and Sharing Policy). This applies to grant applications submitted for due dates on or after May 25, 2026⁶¹. Other policy notices released were related to:

• Update of NIH Late Application Submission Policy and End of Continuous Submission⁶²,
• Applicability of Transparency Act Subaward Reporting Requirements⁶³,
• Continuation of Modifications to Peer Review Practices⁶⁴,
• SBIR/STTR Programs⁶⁵,⁶⁶,⁶⁷,⁶⁸,⁶⁹,⁷⁰,
• Announcement of Upcoming System Enforcement of Common Forms and End of NIHs Leniency Period⁷¹,
• Update to Standard Language for Developer Terms of Access in the Terms and Conditions of Award⁷²,
• Notice to Rescind NOT-OD-23-075 “Office of Research Infrastructure Programs (ORIP) implementation of NIH Policy on Acceptance for Review of Applications Requesting $500,000 or More in Direct Costs in Any One Budget Year⁷³, and
• An RFI on Promoting Youth Participatory Action Research Approaches in Prevention Research⁷⁴.

For the extramural community, NIH issued many updates and blog posts related to:

• Good Clinical Practice (GCP) Training Consistent with the International Conference on Harmonisation (ICH) E6 (R3) Meet the NIH Requirement⁷⁵,
• 2026 Extramural Community Days: Securing NIH Controlled-Access Data⁷⁶,
• Feedback on Revised Clinical Trial Application Form to Reduce Burden and Enhance Review⁷⁷,
• NIH Awards by Month⁷⁸,
• An Update on Modernizing the NIH Grants and Funding Site: Helping the Research Community Quickly and Easily Understand NIH Funding Policies, Processes, and Activities⁷⁹,
• Current and Pending (Other) Support (CPOS) Common Form⁸⁰,
• Highlighted Topic Interest⁸¹,
• How Centralized NIH Peer Review is Strengthening Efficiency, Competition, and Transparency⁸²,
• Application Scoring Explanations⁸³,
• Key Reminders for Applications, Awards, and a New Highlighted Topic⁸⁴,
• 2026 Pilot Data Management and Sharing Plan Format Available⁸⁵, and the
• NIH Data Book⁸⁶.

In intramural news:

• NIH identified a novel, highly potent opioid that shows potential as a therapy for both pain and opioid use disorder. In a study published in Nature, the team observed the new drug’s effect in laboratory animals⁸⁷.
• An NIH clinical trial found that a scalable, team-based intervention strategy in federally qualified health centers (FQHCs) was able to significantly reduce systolic blood pressure for low-income participants⁸⁸.
• An NIH-funded research team has discovered an enhanced CRISPR gene-editing system that could enable targeted delivery inside the human body⁸⁹.
• Dr. Jonathan M. Green selected as CEO of the NIH Clinical Center⁹⁰.
• NIH researchers researchers developed a cancer assessment tool (scSurvival) that can identify high-risk patients and the tumor cells linked to that risk. The model uses a machine learning framework designed to analyze large-scale data at single-cell resolution⁹¹.
• An NIH-supported clinical trial compared two commonly used treatments for pediatric patients treated for septic shock and found no difference in meaningful outcomes⁹².
• Another NIH clinical study showed that a symptom-based treatment for babies with neonatal opioid withdrawal syndrome (NOWS) could speed up their recovery⁹³.

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Inside GAO

GAO listed three emerging technologies that may require congressional attention within the next 10 years:

• Neural implants for human augmentation,
• General purpose robots, and
• Orbital debris removal technologies.

Though recommendations were not provided, GAO identified several policy considerations for the Congress and others to weigh as these technologies continue developing⁹⁴.

GAO observed the pay and benefit trends for graduate students and postdoctoral researchers. They found that they were paid less than others with the same level of education and that the National Science Foundation (NSF) doesn’t collect enough data to fully analyze compensation for these researchers⁹⁵.

Other reports include:

• GAO identified trade-offs facing agencies as they acquire artificial intelligence (AI), and some associated challenges and benefits⁹⁶.
• GAO found that when recipients (e.g., universities and businesses) invented useful technologies, most chose to retain ownership rights, while about 21 percent declined to do so, from fiscal year 2020 through 2024 (see figure). The most common reason they declined was low commercial potential for the inventions (meaning they would not be likely to find a commercial partner to bring the invention to market, according to university representatives). This is in relation to the Bayh-Dole Act⁹⁷.
• GAO was asked to review recent initiatives to support agencies’ ability to collaboratively address grants management challenges. This report describes: 1) the government-wide legal and administrative framework for federal grants management and 2) how member agencies communicate and collaborate through the Council on Federal Financial Assistance (COFFA)⁹⁸.
• GAO found about a quarter of the major rules issued from January 21, 2021, to January 20, 2025 (119 of 462 rules), agencies published effective dates inconsistent with the Congressional Review Act’s (CRA) 60-day waiting period. The waiting period begins when the Federal Register has published the rule or the House and the Senate have received paper copies, whichever is later, and does not apply under certain exceptions, such as when agencies claim good cause⁹⁹.
• GAO found that 156 of the 258 appropriation accounts in their review of the Consolidated Appropriations Act, 2023 had budget authority available for obligation in fiscal year 2026 or later, as of September 30, 2025. These accounts had approximately $20.9 billion in unobligated budget authority, or about 1.97 percent of the approximately $1 trillion initially appropriated that had a period of availability of fiscal year 2026 or later¹⁰⁰. 
• GAO expressed that space-based data centers would place data processing and storage systems for AI and other computing needs into satellites. This could reduce the land, electricity, and water needed for data centers on Earth¹⁰¹.

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Other Federal Agency News

• Department of State
  • A rule was published which defined the membership and operating procedures of the Department of State’s Security Review Committee, an internal panel that reviews serious security incidents¹⁰².
• National Science Foundation (NSF)
  • NSF’s National Science Board (NSB) received an e-mail from the Administration that their positions were terminated effective immediately¹⁰³. The NSB has overseen the NSF and provided support for the American research enterprise that is central to the nation’s economic and geopolitical leadership, making this a cornerstone to NSF’s success¹⁰⁴.
  • NSF also issued an RFI to invite feedback a comprehensive review of the Presidential Awards for Excellence in Mathematics and Science Teaching (PAEMST) program and the Presidential Awards for Excellence in Science, Mathematics, and Engineering Mentoring (PAESMEM) program¹⁰⁵.

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Inside the White House

S. 3971, the “Small Business Innovation and Economic Security Act”, is authorized through FY2031. S. 3971 amends the Small Business Innovation Research (SBIR) program, Small Business Technology Transfer program (STTR), and related pilot programs¹⁰⁶.

Trump signed an executive order (EO) that will accelerate access to treatments for patients with serious mental illness. The EO directs the FDA Commissioner to provide National Priority Vouchers to appropriate psychedelic drugs that have received Breakthrough Therapy designations for treating serious mental illnesses. The FDA must work with the DEA to establish a pathway for eligible patients to access investigational psychedelic drugs. Further, the order requires the HHS and the FDA to collaborate with the Department of Veterans Affairs and the private sector to increase clinical trial participation and evidence generation surrounding experimental psychedelic therapies¹⁰⁷,¹⁰⁸,¹⁰⁹,¹¹⁰,¹¹¹.

The Council on Environmental Quality (CEQ), in collaboration with NASA’s Center of Excellence for Collaborative Innovation opened its “Permitting Innovators Call for Solutions” inviting technology companies, startups, researchers, and non-profits to help modernize federal permitting for the 21st century. The Call for Solutions is now open through June 2, 2026, at 6:00 p.m. ET¹¹².

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Inside Congress

The Investigations and Oversight House Subcommittee (of the House Committee on Science, Space, and Technology) held a hearing which examined the current state of scientific publishing, including open access policies, the current state of peer review, conflict of interest policies, data access and reproducibility, emergence of predatory journals, paper mills, and “publish or perish” systems that prioritize publication quantity over quality. Emerging technologies (e.g., artificial intelligence (AI)) were also evaluated to assess its influence on the quality of science, scientific integrity, scientific misconduct, and the advancement of gold-standard science¹¹³.

The Senate Committee on Health, Education, Labor, & Pensions (HELP) held a hearing to discuss the FY2027 HHS Budget. Per Robert F. Kennedy, Jr.’s testimony, the emerging priorities of the HHS Budget include:

• Broader agency reform and efficiency,
• Chronic disease and prevention,
• Healthcare costs and system performance,
• Medicaid/Medicare spending, and
• Public health policy direction¹¹⁴,¹¹⁵.

In other news:

• House Science, Space, and Technology Committee Chairman Brian Babin issued a statement in recognition of the Artemis II crew’s safe return home following a successful splashdown, concluding a landmark mission¹¹⁶.
• House Science, Space, and Technology Committee Chairman Brian Babin, along with Investigations and Oversight Subcommittee, sent a letter to Dr. Marcia McNutt, President of the National Academies of Sciences, Engineering, and Medicine (NASEM), requesting information related to NASEM’s report on Anthropogenic Greenhouse Gases and U.S. Climate: Evidence and Impacts¹¹⁷.

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References

1. Statement of Organization, Functions, and Delegations of Authority; Office of The National Coordinator for Health Information Technology (HHS Federal Register) ↩︎
2. Statement of Organization, Functions, and Delegations of Authority (HHS Federal Register) ↩︎
3. ORI: Apply for 2026 Event Co-sponsorship Opportunities (ORI Press Release) ↩︎
4. ARPA-H launches groundbreaking, $144 million program to combat toxic microplastics in the human body (HHS Press Release) ↩︎
5. HHS, EPA Announce Historic Actions to Protect Americans from Microplastics and Safeguard Drinking Water (HHS Press Release) ↩︎
6. Proposed Rule: Reducing Bureaucracy and Burden for Community Services Programs (HHS Federal Register) ↩︎
7. HRSA Announces More Than $135 Million to Expand Nutrition Services and Strengthen Rural Health Workforce (HHS Press Release) ↩︎
8. HHS Replaces Legacy COBOL Payroll System, Delivering Faster, More Reliable Services (HHS Press Release) ↩︎
9. Secretary Kennedy Advances MAHA Agenda in Arizona with Focus on Prevention, Recovery, and Tribal Health (HHS Press Release) ↩︎
10. HHS Announces $4 Million KidneyX EMPOWER Prize Challenge and Health Technology Project to Advance Living Kidney Donation and Patient-Centered Innovation (HHS Press Release) ↩︎
11. Secretary Kennedy Appoints Casey B. Mulligan as HHS Chief Economist and Regulatory Officer (HHS Press Release) ↩︎
12. ARPA-H announces first research teams for $139 million initiative to transform behavioral health and bring new, more precise and effective treatments to Americans (HHS Press Release) ↩︎
13. Research Misconduct Finding: Ariel Fernandez (ORI Update) ↩︎
14. Real-World Evidence: Advancing Regulatory Decision-Making for Medical Devices (FDA Voices) ↩︎
15. Examples of Real-World Evidence Used in Medical Device Regulatory Decisions (Fiscal Years 2020–2025) (FDA CDRH News) ↩︎
16. FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results (FDA Press Release) ↩︎
17. FDA Takes Step Forward on Testosterone Therapy for Men (FDA Press Release) ↩︎
18. Notice: Potential New Indication for Testosterone Replacement Therapy (FDA Federal Register) ↩︎
19. Notice: Regional Data Elements and Implementation Schedule: Electronic Submission of Postmarketing Individual Case Safety Reports to the Food and Drug Administration Adverse Event Monitoring System Using International Council of Harmonisation E2B(R3) Data Standards (FDA Federal Register) ↩︎
20. FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development (FDA Press Release) ↩︎
21. Regulatory Education for Industry (REdI) Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products (FDA Event) ↩︎
22. Rule: Medical Devices: Ear, Nose, and Throat Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for the Relief of Congestion (FDA Federal Register) ↩︎
23. Rule: Medical Devices: Orthopedic Devices; Classification of the Manual Surgical Instrument for Appropriate Patient Selection for Orthopedic Implant (FDA Federal Register) ↩︎
24. Rule: New Animal Drugs: Approval and Withdrawal of Applications; Change of Sponsor; Change of Sponsor Address (FDA Federal Register) ↩︎
25. Rule: Physical Medicine Devices: Reclassification of Non-Invasive Bone Growth Stimulators (FDA Federal Register) ↩︎
26. Rule: Medical Devices: Anesthesiology Devices; Classification of the Device for Sleep Apnea Testing Based on Mandibular Movement (FDA Federal Register) ↩︎
27. Rule: Medical Devices: Clinical Chemistry and Clinical Toxicology Devices; Classification of the Setmelanotide Eligibility Gene Variant Detection System (FDA Federal Register) ↩︎
28. Rule: Medical Devices: Immunology and Microbiology Devices; Classification of the Alzheimer’s Disease Pathology Assessment Test (FDA Federal Register) ↩︎
29. Rule: Medical Devices: Ophthalmic Devices; Classification of the Digital Therapy Device for Amblyopia (FDA Federal Register) ↩︎
30. Rule: Medical Devices: Cardiovascular Devices; Classification of the Laser-Powered Inferior Vena Cava Filter Retrieval Catheter (FDA Federal Register) ↩︎
31. Rule: Medical Devices: Neurological Devices; Classification of the Brain Temperature Measurement System (FDA Federal Register) ↩︎
32. 
    Rule: Medical Devices: Radiology Devices; Classification of the Radiation Therapy Marking Device (FDA Federal Register) ↩︎
33. Notice: Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments (FDA Federal Register) ↩︎
34. Bioanalytical Method Validation for Biomarkers (FDA Final Guidance) ↩︎
35. Notice: Guidance: Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing (FDA Federal Register) ↩︎
36. Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing (FDA Draft Guidance) ↩︎
37. FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development (FDA Press Release) ↩︎
38. Notice: Guidance: Compliance Policy Regarding Premarket and Other Requirements for Certain National Institute for Occupational Safety and Health Approved Air-Purifying Respirators (FDA Federal Register) ↩︎
39. Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators: Draft Guidance for Industry and Food and Drug Administration Staff (FDA Draft Guidance) ↩︎
40. Notice: Guidance: Establishing Impurity Specifications for Antibiotics (FDA Federal Register) ↩︎
41. Establishing Impurity Specifications for Antibiotics (FDA Draft Guidance) ↩︎
42. Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers (FDA Final Guidance) ↩︎
43. Notice: Guidance: International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing for Medicated Premixes (Revision 1) (FDA Federal Register) ↩︎
44. FDA Approves First New Molecular Entity Under National Priority Voucher Program (FDA Press Release) ↩︎
45. FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program (FDA Press Release) ↩︎
46. WTAS: FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program (FDA Press Release) ↩︎
47. SOPP 8001.4: Review of Proprietary Names for CBER Regulated Products (FDA CBER Biologics Procedures) ↩︎
48. SOPP 8212: Breakthrough Therapy Products – Designation and Management (FDA CBER Biologics Procedures) ↩︎
49. SOPP 8216: Fast Track Development Programs – Designation and Management (FDA CBER Biologics Procedures) ↩︎
50. SOPP 8404.1: Procedures for Filing an Application When the Applicant Protests a Refusal to File Action (File Over Protest) (FDA CBER Biologics Procedures) ↩︎
51. 510(k) Third Party Performance Report – FY26, Q1 (FDA Press Release) ↩︎
52. FDA READI-Home Innovation Challenge: Reducing Readmissions through Device Innovation for the Home (FDA CDRH News) ↩︎
53. April 2026 MedSun Newsletter (FDA CDRH News) ↩︎
54. eMDR – Electronic Medical Device Reporting (FDA CDRH News) ↩︎
55. FDA-Industry MDUFA VI Reauthorization Meeting, March 11, 2026 (FDA CDRH News) ↩︎
56. Meeting Minutes: FDA-Industry MDUFA VI Reauthorization Meeting, March 18, 2026 (FDA CDRH News) ↩︎
57. CMS and FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices (FDA Press Release) ↩︎
58. C3TI Compass (Knowledge Repository) (FDA Announcement) ↩︎
59. Notice: Request for Information: AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program (FDA Federal Register) ↩︎
60. FDA Announces Major Steps to Implement Real-Time Clinical Trials (FDA Press Release) ↩︎
61. NOT-OD-26-067: Implementation of Changes for Basic Experimental Studies with Humans (NIH Policy Notice) ↩︎
62. NOT-OD-26-064: Update of NIH Late Application Submission Policy and End of Continuous Submission (NIH Policy Notice) ↩︎
63. NOT-OD-26-066: Applicability of Transparency Act Subaward Reporting Requirements (NIH Policy Notice) ↩︎
64. NOT-OD-26-069: Continuation of Modifications to Peer Review Practices (NIH Policy Notice) ↩︎
65. NOT-OD-26-072: Update – NIH Implementation of Uniform Administrative Requirements for Federal Financial Assistance (NIH Policy Notice) ↩︎
66. NOT-OD-26-073: Notice of Information: Implementation of HHS Annual SBIR/STTR Application/Proposal Limit (NIH Policy Notice) ↩︎
67. NOT-OD-26-074: Notice of Information: Policy Changes to SBIR and STTR Foreign Disclosure and Risk Management (NIH Policy Notice) ↩︎
68. NOT-OD-26-075: Notice of Information: Policy changes to SBIR and STTR Discretionary Technical and Business Assistance (NIH Policy Notice) ↩︎
69. NOT-OD-26-076: Notice to Rescind NOT-OD-24-077 “Technical and Business Assistance (TABA) Funding May be Added to an SBIR/STTR Award by Administrative Supplement” (NIH Policy Notice) ↩︎
70. It’s Official: NIH’s Small Business Program Is Back (NIH Extramural News) ↩︎
71. NOT-OD-26-079: Announcement of Upcoming System Enforcement of Common Forms and End of NIHs Leniency Period (NIH Policy Notice) ↩︎
72. NOT-OD-26-078: Update to Standard Language for Developer Terms of Access in the Terms and Conditions of Award (NIH Policy Notice) ↩︎
73. NOT-OD-26-071: Notice to Rescind NOT-OD-23-075 “Office of Research Infrastructure Programs (ORIP) implementation of NIH Policy on Acceptance for Review of Applications Requesting $500,000 or More in Direct Costs in Any One Budget Year” (NIH Policy Notice) ↩︎
74. ↩︎
75. Does Good Clinical Practice (GCP) Training Consistent with the International Conference on Harmonisation (ICH) E6 (R3) Meet the NIH Requirement? (NIH Extramural News) ↩︎
76. 2026 Extramural Community Days: Securing NIH Controlled-Access Data (NIH Extramural News) ↩︎
77. NIH Invites Input on a Revised Clinical Trial Application Form to Reduce Burden and Enhance Review (NIH Extramural News) ↩︎
78. NIH Awards by Month (NIH Extramural News) ↩︎
79. An Update on Modernizing the NIH Grants and Funding Site: Helping the Research Community Quickly and Easily Understand NIH Funding Policies, Processes, and Activities (NIH Extramural News) ↩︎
80. What Should I Know About the Current and Pending (Other) Support (CPOS) Common Form? (NIH Extramural News) ↩︎
81. So, I’m Interested in a Highlighted Topic…What Do I Do Now? (NIH Extramural News) ↩︎
82. One Year Later: How Centralized NIH Peer Review is Strengthening Efficiency, Competition, and Transparency (NIH Extramural News) ↩︎
83. My Application Was Scored as “Competitive But Not Discussed” During Review. What Does This Mean? (Extramural News) ↩︎
84. Embedding Replication and Reproducibility Throughout NIH Research: Key Reminders for Applications, Awards, and a New Highlighted Topic (Extramural News) ↩︎
85. 2026 Pilot Data Management and Sharing Plan Format Available (NIH Extramural News) ↩︎
86. Explore the NIH Data Book — New Fiscal Year 2025 Updates and More Are Underway (NIH Extramural News) ↩︎
87. NIH researchers discover pain-relieving drug with minimal addictive properties (NIH Intramural News) ↩︎
88. Low-cost care model reduces blood pressure in high-risk populations (NIH Intramural News) ↩︎
89. NIH-funded breakthrough shrinks CRISPR for precision delivery in the body (NIH Intramural News) ↩︎
90. Dr. Jonathan M. Green selected as CEO of the NIH Clinical Center (NIH Intramural News) ↩︎
91. NIH-funded AI model predicts cancer survival from single-cell tumor data (NIH Intramural News) ↩︎
92. Clinical trial finds no difference in fluid treatment options for pediatric sepsis (NIH Intramural News) ↩︎
93. Symptom-based approach treats opioid withdrawal in newborns with minimal drug exposure (NIH Intramural News) ↩︎
94. On the Horizon: Three Science and Technology Trends That Could Affect Society (GAO Report) ↩︎
95. STEM: Additional Data Needed on Graduate Researcher and Postdoctoral Scholar Compensation (GAO Report) ↩︎
96. Artificial Intelligence Acquisitions: Agencies Should Collect and Apply Lessons Learned to Improve Future Procurements (GAO Report) ↩︎
97. Technology Transfer: Funding Recipients Keep Most Federally Funded Inventions, but Some Cited Reporting Challenges (GAO Report) ↩︎
98. Grants Management: Efforts to Address Challenges Through Government-wide Collaboration (GAO Report) ↩︎
99. Congressional Review Act: Agencies and Congress Could Improve Implementation of 60-Day Delay for Major Rules (GAO Report) ↩︎
100. Federal Budget: Remaining Budget Authority from the Consolidated Appropriations Act, 2023 (GAO Report) ↩︎
101. Science & Tech Spotlight: Data Centers in Space (GAO Report) ↩︎
102. Rule: Security Review Committee (Department of State Federal Register) ↩︎
103. Entire NSF science advisory board fired by Trump administration (Nature Article) ↩︎
104. National Academies Presidents’ Statement on Value of National Science Board (National Academies Press Release) ↩︎
105. Notice: Request for Information (National Science Foundation Federal Register) ↩︎
106. Congressional Bills S. 1884 and S. 3971 Signed into Law (White House News) ↩︎
107. Accelerating Medical Treatments for Serious Mental Illness (White House News) ↩︎
108. Fact Sheet: President Donald J. Trump is Accelerating Medical Treatments for Serious Mental Illness (White House News) ↩︎
109. Executive Order: Medical Treatments for Serious Mental Illness; Acceleration Efforts (EO 14401) (White House Federal Register) ↩︎
110. FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order (HHS Press Release) ↩︎
111. FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order (FDA Press Release) ↩︎
112. CEQ Opens Permitting Innovators Call for Solutions to Industry Partners (White House News) ↩︎
113. Investigations and Oversight Subcommittee Hearing – The State of Scientific Publishing: Assessing Trends, Emerging Issues, and Policy Considerations (House Committee on Science, Space, and Technology) ↩︎
114. NEXT WEEK: Senate HELP Committee to Hold Hearing with Secretary Kennedy on HHS Budget (Senate HELP Press Release) ↩︎
115. Hearing on Fiscal Year 2027 Department of Health and Human Services Budget (Senate HELP Press Release) ↩︎
116. Chairman Babin Applauds Artemis II Crew’s Successful Splashdown and Historic Mission (House Committee on Science, Space, and Technology Press Release) ↩︎
117. SST Leaders Request Information from NASEM on Greenhouse Gas Study and Committee Practices (House Committee on Science, Space, and Technology Press Release) ↩︎

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